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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.

 

 

Abbott VOLT-AF IDE Study

This research study will collect data to demonstrate safety and effectiveness of the Volt Pulsed Field Ablation (PFA) System for the treatment of Atrial Fibrillation (AF). It will enroll patients who are scheduled to undergo an ablation for treatment of AF. The Volt PFA System is an investigational device. This means that it is not approved by the Food and Drug Administration (FDA) to treat AF.

Advanced TeleSensors - Heart Rate and Respiratory Rate Measurements by the Novel, Radar-based CARDI/O ATX-2410 Remote Cardiac Monitor

The purpose of this study is to determine the accuracy of monitoring heart rate and respiratory (breathing) rate measured by the Cardi/o ATX-2410 device in patients seeing a doctor in a clinical setting. Cardi/o is a contactless, wireless, radar-based sensing monitor for heart rate, and respiratory rate within approximately 3 meters of the device using Wi-Fi. The device passively monitors a patient and transmits information, including continuous heart and respiratory rate and alerts to a healthcare professional’s workstation or phone-based application. 

Atricure HEAL-IST IDE Trial - Hybrid Epicardial and Endocardial Sinus-Node SpAring AbLation Therapy for Inappropriate Sinus Tachycardia
The purpose of this research trial is to learn more about the safety and effectiveness of the ISOLATOR® Synergy Surgical Ablation System in subjects who have been diagnosed with Inappropriate Sinus Tachycardia (IST). Enrolled subjects will undergo a hybrid sinus node sparing ablation procedure to treat their IST.

AtriCure’s ISOLATOR® Synergy Surgical Ablation System has been cleared under the 510(k) process by the United States Food and Drug Administration (FDA) to ablate the heart to treat cardiac arrhythmias in patients undergoing open heart surgery. It is currently in commercial use in the US and various European countries however for the purposes of this trial will be labeled for Investigational Use Only.

AtriCure IST Registry - Inappropriate Sinus Tachycardia Registry
The purpose of this registry is to collect real-world safety and performance data when registry sites perform a hybrid ablation procedure to treat Inappropriate Sinus Tachycardia (IST) or Postural OrthostaticTachycardia Syndrome (POTS) which includes the use of one or more AtriCure devices to ablate cardiac tissue. It will enroll patients who have chosen to have or have undergone an ablation treatment for IST or POTS using one or more AtriCure cardiac ablation devices.
Attune Medical - Improving Oesophageal Protection During Atrial Fibrillation (AF) Ablation: A Multicentre Study
Part of the standard atrial fibrillation (AF) ablation procedure involves performing ablation on part of the heart next to the esophagus (the tube between the mouth and the stomach). Sometimes the heat from the ablation in this area can also cause damage to the esophagus. The purpose of this study is to see if esophageal cooling using the Attune Medical Esophageal Heat Transfer (ensoETM) study device limits damage to the esophagus during AF ablation procedure.

The ensoETM is a Food and Drug Administration (FDA) cleared device used for temperature control but is not commonly used during ablation procedures.

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

Biosense Webster OMNY-AF - Assessment of Safety and Effectiveness in Treatment Management of Paroxysmal Atrial Fibrillation with the BWI Pulsed Field Ablation System with OMNYPULSE Catheter

This study will enroll patients who have been diagnosed with symptomatic Paroxysmal Atrial Fibrillation (PAF) and have decided to undergo cardiac ablation. The purpose of this research study is to provide information about the safety and long-term effectiveness of the BWI OMNYPULSE™ Pulsed Field Ablation (PFA) Platform, consisting of the TRUPULSE™ Generator and OMNYPULSE™ Catheter used in conjunction with the CARTO®3 System with the VISITAG SURPOINT™Module PF Index to treat symptomatic PAF. The BWI OMNYPULSE™ PFA Platform is an investigational device that has not been approved by the FDA.

Biosense Webster SmartPULSE PAF - Safety and Effectiveness Evaluation of the THERMOCOOL 4 SMARTTOUCH™ SF Catheter with the TRUPULSE™ Generator for 5 treatment of drug refractory symptomatic Paroxysmal Atrial Fibrillation (PAF)
This study will enroll patients who are scheduled to undergo ablation to treat paroxysmal atrial fibrillation (PAF). The purpose of this study is to provide information about the safety and long-term effectiveness of the Biosense Webster, Inc (BWI) Pulsed Field (PF)/Radiofrequency (RF) ablation system consisting of the TRUPULSE™ Generator and THERMOCOOL SMARTTOUCH™ SF (STSF) Catheter. The BWI PF/RF Ablation system is being studied for the treatment of PAF.

The BWI PF/RF Ablation system is an investigational device that has not been approved by the US Food and Drug Administration (FDA) for the treatment of PAF.

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

This study is being conducted toe valuate whether a new treatment called the FARAPULSE Pulsed Field Ablation System is safe and works well for people with symptoms of persistent atrial fibrillation (PsAF). The treatment uses a type of electricity that comes in short bursts. 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.

For the Phase II of this study, a specific Insertable Cardiac Monitor (ICM) called LUX-Dx will be inserted if you do not already have one with adequate battery life. It will be used for the detection of abnormal heart rhythms and long-term monitoring.

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.

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

Boston Scientific AVANT GUARD - A Prospective Randomized Multicenter Global Study Comparing Pulsed Field Ablation versus Anti-Arrhythmic Drug Therapy as a First Line Treatment for Persistent Atrial Fibrillation

This trial will compare ablation using the FARAPULSED™ Pulsed Field Ablation (PFA) system vs anti-arrhythmic drug (AAD) therapy as the initial therapy for persistent AF treatment. PFA procedures are done with electrical energy emitted by pulses and are still considered investigational and not yet approved by the Food and Drug Administration (FDA) as an initial treatment for Persistent AF. 

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.

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

Boston Scientific HEAL-LAA - Post-Market Real World Outcomes in WATCHMAN FLX™ Pro Left Atrial 3 Appendage Closure (LAAC) Device
This study will enroll patients who have been implanted or will be implanted with a WATCHMAN  FLX™ Pro Device. The WATCHMAN FLX™ Pro device is approved for commercial use in the United States and is a newly FDA approved version of the previous device called WATCHMAN  FLX™ Device.

This study is observational and will collect and analyze clinical information on patients who receive the WATCHMAN  FLX™ Pro device.

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.
DISRUPT-AF - A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse™ Pulsed Field Ablation Technology for A trial Fibrillation

This is a registry for patients undergoing an ablation using the FDA approved Farapulse system. The purpose of this Registry is to learn more about the outcomes for patients who receive an ablation using the Farapulse™ Pulsed Field Ablation System for the treatment for Paroxysmal Atrial Fibrillation (PAF), Persistent (PsAF) Atrial Fibrillation, and Long-Standing Persistent Atrial Fibrillation (LSPsAF). 

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.

KC Heart Rhythm Research Foundation GI-FLX Registry - Left Atrial Appendage closure with WATCHMAN FLX Device in Recurrent Gastrointestinal Bleeding

The purpose of this research study is to create a prospective registry of patients with a history of GI bleeding who are having a WATCHMAN-FLX device implanted. Patients will receive standard care during the implant and on subsequent follow up visits. Medical records will be collected by study staff throughout participation to assess the success of the implant procedure and assess health status after implantation.

Medtronic Cryo AF Global Registry - STOP Persistent
Participants in this study are scheduled to have a cryoablation procedure using the Medtronic Arctic Front™ System or Freezor™MAX Family of Cardiac Cryoablation Catheters (Arctic Front™) for the treatment of your persistent 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 describe clinical performance and safety data in persistent AF patients treated with the Arctic Front™ and Freezor™MAX Families of Cardiac Cryoablation Catheters, which are approved by the U.S. Food and Drug Administration (FDA).

 

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.
MGH POLARIS - Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients with Paroxysmal and Persistent A

The purpose of this study is to provide information about the safety and long-term effectiveness of the BWI (Biosense Webster) irreversible electroporation (IRE) ablation system consisting of the TRUPULSE™Generator and VARIPULSE™Catheter. It will enroll patients who are scheduled to undergo an atrial fibrillation (AF) ablation to treat AF. 

The BWI IRE Ablation system uses a new type of energy source called pulsed field, which uses ultra-rapid electrical fields on the heart muscle to cause IRE to treat AF. The system is investigational and has not been approved by the Food and Drug Administration (FDA). 

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).

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

PHRI LAAOS-4 - Hamilton Health Sciences Corporation through its Population Health Research Institute (PHRI) / “The Fourth Left Atrial Appendage Occlusion Study"

This study will enroll patients with atrial fibrillation (AF). This condition can decrease the heart’s pumping capacity, which can form clots in the left atrial appendage (LAA) which can escape and lead to stroke. The purpose of the LAAOS-4 study is to determine if closure of the LAA using a closure device called the WATCHMAN™, in addition to taking oral anticoagulant medications (OAC), is more effective at reducing strokes and blood clots than taking OAC medications on their own.

Siemens 2D - Assessment of Utility of Siemens AcuNav Crystal ICE Catheter in Evaluation of Cardiac Anatomy and Physiology During Electrophysiology and Structural Heart Interventional Procedures

This study will enroll patients who are undergoing cardiology procedures that require imaging guidance with intracardiac echocardiography (ICE). Physicians routinely use ICE catheters and machines made by Siemens, and are now investigating a series of “next-generation” Crystal 2D ICE catheters which have a greater number of transducers which are designed to improve image quality and procedural guidance.

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

Siemens 4D - Assessment of Utility of Siemens Healthineers 4D ICE and Premium CV system workflow in Evaluation of Cardiac Anatomy and Physiology During Structural Heart Interventional Procedures

This study will enroll patients who are undergoing cardiology procedures that require imaging guidance with intracardiac echocardiography (ICE). Physicians routinely use ICE catheters and machines made by Siemens, and are now investigating a series of “next-generation” AcuNav 4D ICE catheters which have a greater number of transducers which are designed to improve image quality and procedural guidance.

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

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 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 hdNOAC - Efficacy of Different Anti-Thrombotic Strategies After Percutaneous Left Atrial Appendage Occlusion (LAAO)
The purpose of this study is to study the efficacy and safety of antiplatelet therapy (APT) versus half dose novel oral anticoagulation (hdNOAC) after Watchman FLX implantation.
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 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 PREDICT-CLOT - BioMarker profile in patients developing device thrombus post-LAA occlusion

This study will enroll patients who have had or will be undergoing a left atrial appendage occlusion (LAAO) procedure. A rare but known complication is the development of a clot on the LAAO device. This study will evaluate blood samples to identify blood protein biomarkers that could predict clot formation. The purpose of this study is to examine the association of blood-proteins with LAAO-related clot. 

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 SAFFICIENT - Safety and efficacy of pulsed - field ablation for atrial fibrillation in high versus low - volume ablation centers

The purpose of this research is to test the safety of the investigational Biosense Webster Inc (BWI) IRE (irreversible electroporation) Ablation system for people with symptomatic atrial fibrillation (AF). This system uses voltage generated by the TRUPULSE™ Generator when connected to the VARIPULSE™ Catheter using a new type of energy source called pulse field.  It will enroll patients who are undergoing ablation procedure to treat either Paroxysmal AF (PAF) or persistent AF (PerAF). 

This system is investigational and has not been approved by the U.S. FDA for commercial use but has been approved for use during this study

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.