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Abbott Aveir Dual-Chamber Leadless i2i IDE Study

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. 

Abbott 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.

 

 

Acutus 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. 

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.

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

Boston Scientific ADVANTAGE-AF - A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects with Persistent Atrial Fibrillation

The purpose of this study is to evaluate the safety and effectiveness (success) of the FARAPULSE Pulsed Field Ablation System to treat symptomatic persistent atrial fibrillation (PsAF) using pulsed electric energy. This system is made by Boston Scientific Corporation, who is also the sponsor of this research study. The study will enroll patients who have PsAF and are scheduled to undergo a cardiac ablation. 

The FARAPULSE Pulsed Field Ablation System is considered investigational because it is not approved by the Food and Drug Administration (FDA) for use within the United States for the treatment of PsAF.

Boston Scientific 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.

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

Biosense Webster AdmIRE - Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation with the BWI IRE Ablation System

The Biosense Webster Inc. (BWI) IRE (irreversible electroporation) Ablation system is being studied for use in the treatment of paroxysmal atrial fibrillation (PAF). The BWI IRE Ablation system uses a new type of energy source called pulse field. Pulse field ablation applies ultra-rapid (less than 1 second) electrical fields to the heart muscle to cause irreversible electroporation (IRE) to treat AF. This system uses voltage generated by the TRUPULSE™ Generator when connected to the VARIPULSE™Catheter.

The purpose of this study is to provide information about the safety and long-term effectiveness of the BWI IRE ablation system. Patients who are scheduled to undergo an ablation procedure to treat PAF will be enrolled at up to 40 centers in the US. 

This system is investigational and has not been approved by the U.S. FDA.

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

Biosense Webster (Coherex) 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.

Boston Scientific 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.

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

Cleveland Clinic WATCH RWE - WATCHMAN FLX Real World Evidence

The purpose of this research study is to collect real world clinical outcomes data for patients who are implanted with the WATCHMAN FLX device in a commercial clinical setting. The registry will collect both short and long-term data on a large group of patients post FDA approval. Data collection is anticipated to last approximately 2 years.

CONFORM Medical Pivotal Trial - An Evaluation of the Safety and Effectiveness of the Conformal CLAAS System for Left Atrial Appendage Occlusion

This clinical study is testing an investigational device called the CLAAS device which is specifically designed to be permanently implanted in the left atrial appendage (LAA) of the heart and block off any blood flow to the appendage. This study will evaluate the safety and effectiveness of the CLAAS device in the sealing of the LAA for the prevention of stroke and stroke related complications associated with atrial fibrillation (AF). The study will enroll patients who have AF, which can cause blood clots to form in the LAA. 

The CLAAS device is investigational and not approved by the United States Food and Drug Administration (FDA). 

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.

Dignity Health 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. 

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.

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

Impulse Dynamics 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%.

Impulse Dynamics INTEGRA-D - Assessment of the Safety and Efficacy of a Combined Cardiac Contractility Modulation and Implantable Cardioverter Defibrillator Device for Subjects with Heart Failure and Reduced Ejection Fraction

This research study is designed to determine if the combination of cardiac contractility modulation therapy (CCM) and implantable cardioverter-defibrillator (ICD), as an investigational device (OPTIMIZER INTEGRA CCM-D System) can effectively defibrillate and treat episodes of VT/VT should any occur. The OPTIMIZER INTEGRA CCM-D System, also known as a “Cardiac Contractility Modulation–Defibrillator”, is an investigational device system that combines CCM therapy and ICD therapy into one device. It is not approved by the U.S. Food and Drug Administration (FDA). 

Impulse Dynamics 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. 

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 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 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.

Medtronic 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).

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

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.

Mt. Sinai Ultra-HFIB: Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation Ablation: 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).

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).

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. 

Sentreheart 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. 

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.

UCSF 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. 

TCAI 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.

TCAI 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.

TCAI 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.

TCAI 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.

TCAI IVTCC: An International VT Ablation Center Collaborative Group: Multi-center Ventricular Tachycardia Catheter Ablation Registry

The purpose of this study is to create an international clinical registry related to patients with ventricular arrhythmias. The registry will be used to build a database to track specific information related to ventricular tachycardia (VT) and premature ventricular contraction (PVC) ablations that can be used for clinical monitoring and quality improvement, research, and to help guide new therapies. 

TCAI Janssen Heartline - A Heart Health Study Using Digital Technology to Investigate if Early Atrial Fibrillation (AF) Diagnosis Reduces the Risk of Thromboembolic Events Like Stroke in the Real-World Environment

This study will enroll patients who are aged 65 and older. It seeks to determine whether a heart healthy Engagement Program delivered via the Heartline application (Heartline app) on the iPhone and Apple Watch can lead to successful identification and diagnosis of atrial fibrillation (AF). 

TCAI 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.

TCAI Mt Sinai AACCRUe Registry - The Atrial Appendage Closure ConsoRtiUm Registry

This observational registry will enroll patients who have undergone a left atrial appendage closure (LAAC) with an FDA approved device. The objective is to establish a national registry of all patients with atrial fibrillation (AF) who have undergone LAAC for stroke prevention in an effort to better understand outcomes and complications associated with LAAC. 

TCAI PLATINUM - Impact of post-ablation alcohol intake on arrhythmia recurrence, quality of life and cognition in patients with atrial fibrillation

The purpose of this study is to assess how alcohol-drinking affects ablation-outcome in terms of recurrence and burden of arrhythmia, quality of life and cognitive functions during the first 8 months following catheter ablation. It will enroll patients who are scheduled to undergo their first catheter ablation procedure for atrial fibrillation (AF) and drink at least 5 alcoholic beverages per week. 

TCAI - Prospective Database of Patient having heart rhythm disorder

The purpose of this database is to facilitate patient-outcomes research. The database will combine data from Electrophysiology procedures from existing clinical-data sources maintained by St. David’s HealthCare, physician practices and outpatient clinics, including electronic health records, laboratory results, pathology results, data collection forms, and imaging scans. Data collection will allow TCAI physicians and researchers to study longer-term outcomes in large patient populations and help improve patient management. 

TCAI TAP-CHF - A Phase 4, Randomized, Open Label, Multicenter Prospective Comparative Study to Evaluate the Treatment of Atrial Fibrillation in Preserved Cardiac Function Heart Failure
This is a two-phase study for patients who have had one or more episodes of both heart failure and atrial fibrillation (AF). 
 
The first phase of the study will compare two commonly used, approved treatment strategies for AF – medication and catheter ablation. 
 
The second phase of the study will compare two commonly used, approved treatment strategies for heart failure – medication administered by your doctor or medication administered by a pressure monitor implant. 
 
Each phase is randomized, so participants will be randomly (by chance) assigned to receive one of the two commonly used treatment strategies.