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AcQMap® US Registry of Procedural and Long-term Clinical Outcomes (Discover-US)

The purpose of this registry is to collect additional data on the performance of the AcQMap System. It will enroll patients scheduled for an ablation procedure to treat a complex arrhythmia (irregular heartbeat). This registry will evaluate the AcQMap System. This new imaging and mapping system is approved by the Food and Drug Administration (FDA) and is designed to allow the doctor to “map” the exact places the impulses come from within the heart in order to better target the best places for the ablation. Use of this new diagnostic method of “mapping” will not change the other devices (such as ablation catheters) used for the ablation. 

Adagio Medical iCLAS for Persistent Atrial Fibrillation

This study will enroll patients who are scheduled to undergo a catheter ablation for atrial fibrillation (AF). The ablation catheter used in this study uses cryoenergy (freezing) instead of radiofrequency (heating) energy to eliminate the unwanted electrical impulses. The study will investigate if the linear ablation (lines) that the catheter is designed to create are safe and effective in the treatment of persistent AF. The iCLAS system is an investigation device system which means it is not approved by the United States Food and Drug Administration (FDA) to be used commercially. 

AFFERA Sphere-9 - Treatment of Persistent Atrial Fibrillation with the Sphere-9™ Mapping and Ablation Catheter and the Affera Mapping and Ablation System

The purpose of this study is to demonstrate that the Sphere-9™ Mapping and Ablation Catheter System (Sphere-9™) are safe and effective in treating atrial fibrillation (AF). This device is investigational (experimental) which means it is not approved by the U.S. Food and Drug Administration (FDA), and works by delivering energy to parks of the heart that are responsible for AF. The study will enroll patients who are scheduled to undergo an ablation procedure to treat AF.

AIM - Assessment of Implantable CCM in the Heart Failure Group with Higher Ejection Fraction

This study will enroll patients with heart failure (HF) with a preserved ejection fraction (EF) of 40 – 60%. This group of patients have hearts that pump normally but that is too stiff to relax and fill with enough blood. The purpose of this study is to determine whether Cardiac Contractility Modulation therapy (CCM) will reduce the occurrence of cardiovascular mortality and heart failure hospitalizations in patients with this condition. CCM therapy is delivered by an implantable device called the Optimizer System. 

The Optimizer System is approved by the U.S. Food and Drug Administration (FDA) to treat patients with an EF less than 45%. It is considered investigation for patients in this study which means the study device is not approved by the FDA for patients with an EF greater than 45%.

aMAZE CAP - Left Atrial Appendage Ligation with the LARIAT+®Suture Delivery System as Adjunctive Therapy to Pulmonary Vein Isolation for Persistent or Longstanding Persistent Atrial Fibrillation

The left atrial appendage (LAA) is a small sac about the size of your thumb that hangs off the left atrium. It may add to the abnormal heart rhythm of atrial fibrillation (AF). This study is looking at using a newer non-surgical procedure to close the LAA combined with catheter ablation for persistent AF. By closing the LAA, it is hoped that this may treat AF more effectively as compared to catheter ablation alone. This study involves a device called the LARIAT+ Suture Delivery System (or “LARIAT”) to close the LAA. The purpose of this study is to evaluate the safety and effectiveness of the LARIAT in subjects with Persistent and Longstanding Persistent AF. 

Aveir Dual-Chamber Leadless i2i IDE Study - Abbott

This study will enroll patients who are scheduled to undergo implantation of a dual pacemaker system. The purpose of the study is to evaluate the safety and effectiveness of the Aveir Dual-Chamber leadless pacemaker system in treating patients with a slow heart rate or irregular heartbeats. Unlike traditional pacemaker systems, the leadless system does not require the use of wires or leads placed in the heart to deliver electrical pulses to help control or slow heart rates or irregular heartbeats. It is also smaller than the traditional pacemaker systems.

The Aveir Dual-Chamber leadless pacemaker system is investigational and has not been approved for commercial use by the Food and Drug Administration. 

AWARE - Impact of anxiety on cardiac substrate modification in woman with atrial fibrillation undergoing catheter ablation

Research studies have suggested an association between anxiety disorders and increased risk of AF. This risk is believed to be attributed to chronic inflammation resulting from anxiety which may cause changes in the heart tissue. These inflammatory changes in the heart tissue may initiate non-PV triggers and scar formation in the left atrium (LA – left upper chamber of the heart). Non-PV triggers and LA scar are known risk factors for recurrence of AF after ablation.

The purpose of this study is to evaluate the impact of anxiety on the heart tissue changes leading to non-PV triggers and LA scar in patients after AF ablation.

Bariatric Atrial Restoration of Sinus (BAROS)

This study will enroll patients who have symptomatic Atrial Fibrillation (AF) and qualify for bariatric surgery. A catheter ablation is widely used for the management of AF, but recent studies have shown that weight loss can improve symptoms, quality of life, and reduce the burden of AF. Both AF catheter ablation and bariatric surgery are the standard of care for AF and weight loss, respectively. While weight loss with bariatric surgery is well established, its effect on AF is unknown. This randomized study is designed to evaluate the effect of bariatric surgery on AF catheter ablation in the treatment of AF symptoms and burden.

CATALYST - Clinical trial of atrial fibrillation patients comparing left atrial appendage occlusion therapy to non-vitamin K antagonist oral anticoagulants

The Amplatzer™Amulet™ Left Atrial Appendage (LAA) Occluder (Amulet) device is intended to be permanently implanted within the LAA. The LAA is a small pouch attached to the upper left chamber of your heart, the left atrium. In patients with non-valvular AF, clots can form on the LAA and travel to the brain, sometimes causing an ischemic stroke. The Amulet device is designed to seal off the LAA from blood flow, preventing clots from leaving the LAA and traveling to the brain. 

The purpose of this randomized study is to compare the safety and effectiveness of the Amulet device compared to non-vitamin K antagonist oral anticoagulants (NOACs) for ischemic stroke reduction. Patients will be randomized 50:50 to either receive the Amulet device or receive NOAC therapy.

The Amulet device is approved in some countries outside of the US but is an investigational device in the US.

 

 

CHAMPION-AF - WATCHMAN FLX vs NOAC for Embolic Protection in the Management of Patients with Non-Valvular Atrial Fibrillation

This trial will enroll patients with non-valvular atrial fibrillation (AF). AF can cause blood to pool in the area of the heart called the left atrial appendage (LAA), which can lead to an increased risk for stroke. The current standard of care to prevent stroke in patients with AF is long-term oral anticoagulation (OAC) therapy or, in appropriately selected patients, an implant of a Watchman FLX device. 

The primary objective of this randomized study is to determine if LAA closure with the Watchman FLX device is a reasonable alternative to non-vitamin K oral anticoagulants (NOACs). The Watchman FLX device has been approved by the FDA but is considered investigational for this study. 

COGNITION - Mild cognitive impairment (MCI) in patients with atrial fibrillation (AF), trajectories of the progression of MCI and factors associated with the progression

The purpose of this study is to evaluate the incidence of cognitive impairment in AF and compare two treatment strategies: anti-arrhythmic drugs (AADs) and ablation. Questionnaires will be used to evaluate your cognitive status.

The CONFORMAL Early Feasibility Study (CONFORMAL EFS)

This is an Early Feasibility Study that will evaluate the Conformal Left Atrial Appendage Seal (CLAAS) device. It will determine whether the CLAAS can be safely implanted and evaluate the safety and performance of the CLAAS device in sealing off the Left Atrial Appendage (LAA) for prevention of stroke and stroke related complications associated with atrial fibrillation (AF). The study will enroll patients who have AF and are at an increased risk for stroke and systemic embolism.

The CLAAS device is investigational and not approved by the United States Food and Drug Administration (FDA). This is the first time the CLAAS device has been used in humans.

This study is currently in follow-up only and is not enrolling new patients.

CSPOT - Conduction System Pacing Optimized Therapy

This study will enroll patients who have history of heart failure an are planning to get cardiac resynchronization therapy (CRT) either through an implantable cardioverter defibrillator device (CRT-D device), or through an implanted pacemaker device (CRT-P device). A commercially available CRT device (approved by the U.S. Food and Drug Administration (FDA)) will be implanted. During implantation of the device, the CSPOT Research System will be used to help determine the best mode of CRT pacing, specific for each patient. The CSPOT Research System is investigational. The purpose of this study is to determine the best mode of CRT pacing for CRT patients by comparing three types of resynchronization pacing: 

  • Traditional CRT pacing
  • Conduction System Pacing (CSP) only 
  • CSPOT pacing (i.e CSP + traditional)
CVRx BATwire Implant Kit Study

This study will enroll patients with heart failure who continue to have symptoms despite being treated medication. As such, they qualify to be implanted with the Food and Drug Administration (FDA) approved Barostim Neo System. The purpose of this research study is to describe the safety and effectiveness of the experimental delivery system of the Barostim Neo System called the BATwire Implant Kit. This is done by an ultrasound guided implant procedure. This will be the first time humans will be implanted using the experimental BATwire procedure. The BATwire delivery system is not approved by the FDA.

DASH-AF - Feasibility and Safety of Intravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy in Adult Patients with Atrial Fibrillation

This study will enroll patients who are scheduled to undergo sotalol therapy in a hospital to treat atrial fibrillation (AF). It is investigating the safety and feasibility of an intravenous (IV) dose of sotalol instead of the traditional 3-day oral dose titration that occurs while admitted in the hospital. Patients will be admitted to the hospital in accordance with standard hospital protocol for oral sotalol initiation. 

D-Dimer CLOT - Blood Coagulation Response After Percutaneous Left Atrial Appendage Occlusion

D-dimer is a protein produced when clotting occurs within the body’s blood circulation system. When the left atrial appendage (LAA) is completely sealed, a clot will form inside the LAA and produce D-dimer. This study will evaluate D-dimer levels in the blood before and after a patient has undergone an LAA occlusion procedure to determine if there are changes that could predict complete sealing of the LAA.

DIAMOND AF II - A Prospective Clinical Evaluation of the DiamondTemp™ Ablation System for the Treatment of Persistent Atrial Fibrillation

This study is for patients that are scheduled to undergo Atrial Fibrillation (AF) ablation procedure. The purpose of this clinical study is to see whether the DiamondTemp Ablation catheter System (DiamondTemp) can restore your heart to a normal heart rhythm. DiamondTemp has new technology (network of diamonds in the catheter tip) that allows the tip to be cooled more efficiently. The cooling technology allows for accurate measurement of the heart tissue surface temperature to maintain safe but effective temperatures during ablation. This study will enroll 300 subjects at up to 30 hospitals in the US, Canada, and Europe. Participation will last 12 months.

This study is currently in follow-up only and is not enrolling new patients.

EASY AF Study - Esophagus Deviation and Radiofrequency Ablation of AF

This study will enroll patients who are scheduled or will be scheduled to undergo radiofrequency ablation of atrial fibrillation (AF). During catheter ablation, there is risk of injury to the esophagus which could be fatal. The esophagus is located close to the left atrium of the heart where catheter ablation takes place, often less than 2/10 of an inch (5 millimeters). When the ablation energy is delivered, the heat can radiate or spread from the catheter tip and cause injury to the esophagus. The conventional method to prevent injury to the esophagus is to place a temperature probe and measure changes in the esophagus temperature (ET). 

The purpose of the study is to assess the effectiveness of a product called esolution, which is designed to move the esophagus and to protect it from injury by the radiofrequency energy. It is designed to use vacuum suction to pull the walls of the esophagus inward and then to move the esophagus away from the area of the heart that is being ablated. The esolution device is considered investigational, meaning it is not approved by the Food and Drug Administration (FDA). All other aspects of the ablation procedure involved in this study are approved by the FDA.

The FARAPULSE ADVENT Trial: A Prospective Randomized Pivotal Trial of the FARAPULSE Pulsed Field Ablation System Compared with Standard of Care Ablation in Patients with Paroxysmal Atrial Fibrillation

This study will enroll patients who are scheduled to undergo an ablation to treat atrial fibrillation (AF). The purpose of this study is to evaluate the safety and effectiveness of the FARAPULSE™ Pulsed Field Ablation System and investigate whether using the system helps to reduce the occurrence of AF. The FARAPULSE™ Pulsed Field Ablation System is a new investigational ablation system that involves the use of a catheter in the pulmonary veins connected to the heart. It delivers pulsed electric energy to create scar tissue around the openings of the veins where the misfiring first starts. The system is experimental which means it is not approved by the Food and Drug Administration (FDA) for commercial use. This clinical study is designed to collect data in the United States and compare it to other devices that are currently approved to treat AF.

GSAF - Association of Genetic Variants with Risk of Stroke in Patients with Atrial Fibrillation Off Anticoagulation

The purpose of this study is to examine the association of genetic variants with formation of a blood clot in the heart’s upper left chamber (left atrium) and stroke/TIA in patients remaining off anticoagulation therapy following a left atrial appendage isolation (LAAI) procedure. The study will enroll patients who have undergone an LAAI procedure for AF. Participation will include one blood draw and will last one day.

LEADR - Lead Evaluation for Defibrillation and Reliability

This study will enroll patients who are scheduled to undergo implantation of an Implantable Cardioverter Defibrillator (ICD) or a Cardiac Resynchronization Therapy–Defibrillator(CRT-D) device. An ICD or CRT-D, which is implanted under the skin, works by sending electrical signals to help the heart maintain a steady beat. These devices also sense when the heart is beating in a dangerous way and can send an electric current to re-set the heart to a normal rhythm. Special wires, called leads, connect the ICD or CRT-D to the heart. This study is gathering information about the safety and efficacy of a new lead, called the Next Generation ICD Lead. The Next Generation ICD Lead is investigational because it has not been approved by theU.S. Food and Drug Administration (FDA).

LESS VT - FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of VT

The purpose of this study is to show that the FlexAbility™ SE Ablation Catheter (FlexAbility™) is safe and effective in reducing the number of ventricular tachycardia (VT) episodes in patients who continue to experience VT despite taking antiarrhythmic medications, or who are unable to take antiarrhythmic medications. The FlexAbility™ SE Ablation Catheter is approved in the United States to treat irregular heartbeats in the atria (upper chambers of the heart) and is being used in this study to treat irregular heartbeats in the ventricles (lower chambers of the heart).

Involvement will last for 1 year and up to 592 people will participate at up to 35 sites worldwide.

Lifestyle AF - Impact of Lifestyle Modification On Ablation Outcome in Atrial Fibrillation

The purpose of this research study is to evaluate the impact of aggressive lifestyle modification on the outcome of atrial fibrillation (AF) ablation in overweight and obese patients with AF by using diet and exercise. It will enroll patients that have chronic (long term) AF, and are scheduled to undergo an ablation procedure to treat the AF. You will undergo different levels of diet consultation and exercise to determine their effect on the outcome of the ablation procedure.

LUX-Dx™ Insertable Cardiac Monitor Remote Programming and Performance Study

This study will enroll patients who are scheduled to undergo the implant of a LUX-Dx™ Insertable Cardiac Monitor (ICM) system, which includes a small device that is inserted under the skin of the chest area to monitor and record the heart’s electrical activity (heart rhythm) for the long-term. The purpose of this study is to collect data on how the LUX-Dx ICM system performs in patients who have different kinds of medical conditions that put them at risk for potentially harmful heart rhythms.

The LUX-Dx ICM system is approved for commercial use in the United States. No procedures or devices included in this study are experimental.

MARVEN - Clinical, Electrocardiographic, and Cardiac Magnetic Resonance Imaging Risk Factors Associated with Ventricular Tachyarrhythmias in Nonischemic Cardiomyopathy

This study is for patients with non-ischemic cardiomyopathy who have previously received or are scheduled to receive an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) device. The defibrillator treats rapid abnormal heart rhythms in the lower chambers of the heart. These rhythms are called ventricular tachycardia (VT) and ventricular fibrillation (VF). It is believed that using cardiac magnetic resonance (CMR) imaging may improve the detection of heart damage and identify patients at risk for VT/VF who might benefit from receiving a CRT-D device.

The purpose of this study is to determine what clinical, electrocardiographic (ECG) and CMR factors identify patients at risk for VT / VF. The study involved data collection only. There is nothing investigational. 

Medtronic ADAPT Response Study

CRT device feature called AdaptivCRT (aCRT) will be evaluated in this study. It is designed to automatically optimize CRT pacing therapy by observing patterns in your heart’s contractions and then automatically adjusting your CRT device settings. Currently, an echocardiogram (ultrasound of the heart) or an ECG (records the electrical tracing of the heart’s activity) may be used to provide information needed to program CRT devices. Another option is to use the standard factory settings. This study will investigate the benefits of the aCRT feature compared to these other methods. The aCRT feature is used in addition to standard CRT therapy.

This study is currently in follow-up only and is not enrolling new patients.

Medtronic Cryo AF Global Registry

Participants in this study are scheduled to have a cryoablation procedure using the Medtronic Arctic Front™ System and Family of Cardiac Cryoablation Catheters (Arctic Front™) for the treatment of your atrial fibrillation (AF). This type of procedure targets cardiac tissue that is causing your AF in order to freeze and destroy the abnormal tissue. The purpose of this study is to evaluate and describe clinical performance and safety data in a broad patient population treated with the Arctic Front™ System which is approved by the U.S. Food and Drug Administration (FDA).

 

Medtronic Product Surveillance Registry

The primary purpose of this prospective, non-randomized, multi-center study is to evaluate and publish the long-term reliability and performance of Medtronic market-released cardiac therapy products by analyzing product survival probabilities. Product-related adverse events, indicating the status of the product, will be collected to measure survival probabilities. The data gathered in this study may also be used to support the design and development of investigational plans for new cardiac therapy products.

Milestone Pharmaceuticals Study of Etripamil Nasal Spray for Patients with Paroxysmal Supraventricular Tachycardia

This study is evaluating the safety of a drug called etripamil nasal spray (NS) for patients with paroxysmal supraventricular tachycardia (PSVT).  It is being conducted to help determine how safe and effective etripamil NS is when taken without medical supervision, how well it works to end an episode to PSVT, how it changes symptoms related to PSVT, and how safe and effective it is when taken for more than 1 episode of PSVT.

The drug will be self-administered at home intranasally (that is, sprayed in the nose). Up to 3000 subjects with PSVT at research sites around the world will be enrolled.

OPTIMIZER Smart Post-Approval Study

This study seeks to enroll patients who are scheduled to undergo implantation of the OPTIMIZER Smart device to treat heart failure (HF). HF is treated with medications to improve the strength of the heart muscle and reduce the amount of work the heart must do. However, medications are not always a successful treatment. The OPTIMIZER Smart delivers HF therapy called cardiac contractility modulation, or CCM therapy, to those patients who remain symptomatic despite treatment with medication.

The purpose of this post-approval study (PAS) is to evaluate the safety of long-term use of the OPTIMIZER Smart and CCM therapy. The study will also evaluate the effects of CCM therapy on your quality of life and HF symptoms. 

The Philips ICE Registry

During catheter ablation or left atrial appendage closure procedures, intracardiac imaging (ICE) is routinely used to visualize the heart using Doppler (ultrasound). By transmitting ultrasound signals, ICE imaging provides real-time visualization of the cardiac structures. This study will enroll patients who are scheduled to undergo a procedure that requires the use of ICE. The purpose of this study is to collect basic medical information about that procedure the use of the Philips VeriSight ICE System. The Philips VeriSight ICE system has been approved by the U.S. Food and Drug Administration (FDA).

PIVOTAL - Left Atrial Posterior Wall Isolation in Conjunction with Pulmonary Vein Isolation Using the Cryoballoon for Treatment of Persistent Atrial Fibrillation

This study will enroll patients who are scheduled to undergo an ablation procedure for long duration (persistent) atrial fibrillation (AF). The purpose of this study is to collect information on the safety and effectiveness of ablating (“burn or scar” with extreme cold) the left posterior wall in addition to the pulmonary veins. 

The cryoablation will be performed using the Medtronic Arctic Front Cryoballoon Ablation Catheter System. Though it is approved by the United States Food and Drug Administration (FDA) to treat paroxysmal AF (AF that comes and goes), it is considered investigational for use in patients with persistent AF and for ablation of the posterior left atrial wall or areas outside of the pulmonary veins. 

PLEA - Posterior Wall and/or Left Atrial Appendage Empiric Electrical Isolation for Non-Paroxysmal Atrial Fibrillation

This randomized study is looking to enroll patients who are scheduled to undergo a catheter ablation to treat persistent atrial fibrillation (AF). The purpose of this study is to assess whether ablation of the posterior wall, left atrial appendage (LAA), and coronary sinus, along with standard PV ablation for AF enhances the long-term success rate of catheter ablation. 

This study will be equally randomized to four ablations groups: 1) pulmonary veins alone, 2) pulmonary veins + posterior wall, 3) pulmonary veins + posterior wall + LAA, or 4) pulmonary veins + posterior wall + LAA + coronary sinus. 

PREVENT VT - Prophylactic Cervicothoracic Sympathectomy for Prevention of Ventricular Tachycardia

The purpose of this study to evaluate an additional therapy option for recurrent ventricular tachycardia (VT) called cervicothoracic sympathectomy (CTS). Research has shown that a group of nerves called a ganglia feeding the lower chambers of the heart (ventricles) help start and maintain VT. A surgical procedure called CTS removes a section of these nerves. The goal of this study is to determine whether CTS can prevent VT from occurring, and therefore prevent ICDshocks.

PULSED-AF - Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF

This study will enroll patients who are scheduled to undergo an ablation procedure to treat atrial fibrillation (AF). The purpose of this study is to try to obtain data that may demonstrate the safety and effectiveness of a new ablation system that uses electricity to terminate/stop (ablate) AF rather than radiofrequency, call the Pulsed Field Ablation (PFA) system, for the treatment of AF.

The use of this PFA system in this study is a novel form of treatment in humans and will provide first in-human insights into clinical safety and device function of the PFA system for pulmonary vein isolation and AF ablation.  For this reason, the cardiac ablation procedure will be considered experimental in this study. While some of the PFA system accessories are commercially available, all the components used will be considered investigational when used with the PFA system

This study is currently in follow-up only and is not enrolling new patients.

Samsung Wrist Worn PPG - Validation of Irregular Heart Rhythm Feature Based on Wrist Worn PPG Signals

This study will enroll patients who experience abnormal heart rhythms called atrial fibrillation (AF). Its purpose is to collect data using a variety of medical devices, including commercial available wearables, lab systems, and Samsung’s experimental Galaxy Watch Devices. This data will be used to support the development and validation of the investigational Samsung photoplethysmogram (PPG) app on Samsung wearables. A PPG is a non-invasive measurement of blood volume changes in the small blood vessels in the body. 

St. Jude AMULET - Amplatzer Amulet Left Atrial Appendage Occluder Randomized Controlled Trial

This study is for patients that have nonvalvular atrial fibrillation (AF) and are scheduled to receive a Boston Scientific WATCHMAN LAA occluder device. It is evaluating the AMPLATZER™ Amulet™Left Atrial Appendage Occluder device (AMULET). Like the WATCHMAN device, the AMULET device is designed to reduce the risk of a blood clot from the left atrial appendage (LAA). This purpose of this prospective, randomized, multicenter, active control worldwide trial is to find out if the AMULET device is safe and effective when compared to the WATCHMAN.

This study is currently in follow-up only and is not enrolling new patients.

TactiFlex SE - Safety and Effectiveness of TactiFlex™ Ablation Catheter, Sensor Enabled™ (TactiFlex SE) for the Treatment of Drug Refractory, Symptomatic, Paroxysmal Atrial Fibrillation

This study is for patients that are scheduled to undergo Atrial Fibrillation (AF) ablation procedure. The purpose of this study is to demonstrate that the investigational TactiFlex Sensor Enabled catheter is both safe and effective. The catheter makes use of a sensor to measure the contact force being applied throughout the ablation as well as a magnetic sensor used for tracking with the Ensite Precision Mapping System. This study will enroll 355 patients at up to 40 sites worldwide. Involvement lasts approximately 12-months from the time of the ablation procedure.

This study is currently in follow-up only and is not enrolling new patients.

TRAVERSE - Transseptal vs Retrograde Aortic Ventricular Entry to Reduce Systemic Emboli

This randomized study is for patients who are planning to have a catheter ablation for ventricular tachycardia (VT) and/or premature ventricular contraction (PVC). The purpose of this study is to compare the two different commonly used methods to perform the ablation, transseptal approach vs. retrograde approach, and determine which is better at preventing blood clots or other particles that can travel to the brain and cause possible loss of mental ability. The difference between the two methods (transseptal vs. retrograde) is the way the heart is approached. 

Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation Ablation (Ultra-HFIB): A Pilot Study

This study will enroll patients scheduled to undergo an ablation procedure to treat Atrial Fibrillation (AF) and have high blood pressure. The purpose of this study is to examine the potential additional benefit of performing Renal Sympathetic Denervation (RSDN) at the same time as an AF ablation procedure. It seeks to determine if the procedure can decrease the recurrence of AF and help control high blood pressure, improving the long-term success of the AF ablation procedure. The use of RSDN in this study is investigational, which means it has not been approved by the United States Food and Drug Administration (FDA).

WAVECREST - WaveCrest vs. Watchman Transseptal LAA Closure to Reduce AF-Mediate Stroke 2

This randomized study will enroll patients who have nonvalvular atrial fibrillation (AF) and are scheduled to receive an LAA occluder device. AF increases the risk for blood clots forming in the LAA due to slower blood flow. The LAA is a small pouch on the left upper chamber of your heart called the left atrium. Blood clots in the left side of the heart may go to the brain and cause a stroke. Closing the LAA might prevent blood clots from forming and escaping the LAA.

The purpose of this study is to evaluate the safety and effectiveness of the Coherex WaveCrest® Left Atrial Appendage (LAA) Occlusion System (“WaveCrest device”) by comparing it to a similar device, the Watchman device. The WaveCrest device is investigational, which means it is not approved by the FDA for commercial use in the United States.