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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 Amulet 2 Veritas - Evaluating the safety and effectiveness of Abbott’s Amulet 2 Left Atrial Appendage occluder device
The purpose of this investigational study is to evaluate the safety and effectiveness of the Amulet 2 catheter device used in left atrial appendage occlusion procedures. This study enrolls patients with non-valvular atrial fibrillation who are at an increased risk of ischemic stroke or systemic embolism. Patients must also have an appropriate rationale to seek non-pharmacologic alternatives to oral anticoagulation.

The Amulet 2 device is designed to prevent thrombus embolization in the Left Atrial Appendage. Thrombus embolization is when a blood plot migrates from its original location in a blood vessel, which can lead to an obstruction in the circulatory system. Following the procedure, patients will receive final imaging to ensure proper placement of the device.

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.

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

Adagio Medical - Cryoablation for Monomorphic Ventricular Tachycardia IDE Study: EFS and Pivotal

The purpose of this research is to evaluate the safety and effectiveness of the Adagio Medical vCLAS™Cryoablation System (Adagio System) for the treatment of a heart arrhythmia called Ventricular Tachycardia (VT). It is enrolling patients who are scheduled to undergo cardiac ablation to treat the VT. While the FDA has approved the clinical use of this device in a pre-market investigational device exemption (IDE) study, the device has not been approved by the FDA for commercial use in the US.

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. 

Arga Medtech COHERENT AF - Coherent Sine-Burst Electroporation (CSE) Ablation System US IDE Study for Patients with Atrial Fibrillation
This study evaluates the safety and effectiveness of the investigational Argá Medtech CSE Ablation System for the treatment of atrial fibrillation. The Arga Medtech CSE System is designed to shortening procedural time, minimizing fluoroscopy exposure, and lowering the risk of air emboli associated with multiple catheter exchanges, while also enhancing clinician’s ability to effectively create endocardial lesion sets. The CSE system differs from other PFA systems by providing controlled bursts of micro-second long sine-wave PFA pulses. Other PFA catheters, use monophasic or biphasic square waves rather than sine waves.
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.
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 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.

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

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

Boston Scientific: Rematch - Repeat Ablation of Persistent Atrial Fibrillation, including Mitral Isthmus and Cavo-Tricuspid Isthmus Ablations, with the FARAPULSE Pulsed Field Ablation System
The purpose of this study is to evaluate the safety and effectiveness of the FARAWAVE™
And FARAPOINT™ pulsed field ablation (PFA) catheters for re-treatment of persistent atrial fibrillation (PersAF) after a failed initial procedure. Recurrences of AF are not uncommon after a first ablation procedure. Since PFA is a relatively new ablation modality, clinical evidence regarding use of PFA for repeat procedures is not yet available.

This study recruits patients undergoing a repeat ablation procedure after a recurrence of PersAF, with enrollment lasting approximately 12 months.

Boston Scientific Simplaafy - WATCHMAN FLX™Pro Left Atrial Appendage Closure Device withAlternative Post-Implant Monotherapy

This investigational study aims to understand the most effective treatment plan after a patient receives a WATCHMAN FLX Pro device implant. A WATCHMAN device is commonly used as a preventative measure for patients with atrial fibrillation, to reduce their risk of developing thromboembolism and stroke.  Typically, this condition is treated using stroke prevention drug therapies. However, commonly used drugs. such as Warfarin, have been known to pose a risk for bleeding complications. Patients who receive a Watchman implant, however, have a significantly lower rate of stroke and bleeding. 

Participants enrolled in this study will be randomly assigned to either receive drug therapy or DAPT treatment after their implant procedure. Patients will be monitored for one year post implant, with periodic imaging and testing done to assess the patient’s health.

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 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.

Kardium: Globe® Pulsed Field System for Symptomatic Paroxysmal or Persistent Atrial Fibrillation
This study aims to evaluate the safety and effectiveness of the Globe PF System for treating patients with symptomatic paroxysmal or persistent atrial fibrillation. The Globe Pulsed Field System differs from other PFA catheters because of its ability to map in high-resolution, and deliver radiofrequency and pulse field energy for tissue ablation. The catheter also has spherical geometry optimized to achieve pulmonary vein isolation, and a globe positioning system module, which provides 3K electroanatomic mapping function.

Patients with symptomatic paroxysmal AF (PAF) and Persistent AF (PsAF) may be eligible to enroll in this study.

Laminar Left Atrial Appendage Elimination (LAAX) Pivotal IDE Study

This study will enroll patients who are scheduled to receive a left atrial appendage (LAA) closure device. The purpose of this research study is to compare the safety and effectiveness of the Laminar LAA Closure System as compared to a commercially available LAA closure device to close off the LAA to eliminate a potential source of blood clots. The study will be randomized into one of two groups by a computer. The device is experimental, which means it has not been approved by the Food and Drug Administration (FDA) for commercial sale.

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).
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.

EBR CT vs TTE for WiSE
This study aims to evaluate the feasibility and effectiveness of computed tomography (CT) imaging to identify an appropriate window in the chest wall, suitable for WiSE System transmitter implementation.

The WiSE System delivers leadless LV endocardial pacing for biventricular pacing in Cardiac Resynchronization Therapy (CRT). Transthoracic echocardiography (TTE) is currently used in pre-procedure screening. While effective in many cases, TTE imaging has its limitations, as it is highly operator dependent, and can be impacted by factors such as patient BMI, position of the lungs during respiration, and patient posture. Alternatively, computed tomography (CT) offers high-resolution, reproducible imaging of thoracic anatomy and may provide more reliable visualization of rib spacing, lung position, and left ventricular wall morphology.

Participants who enroll in the study will have previously undergone a CT scan, and will receive a TTE.

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). 

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 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.
Medtronic SPHERE 360 PFA for PAF
The purpose of this study will be to demonstrate an acceptable safety profile of the Sphere-360 Catheter and Affera Mapping and Ablation System for the treatment of paroxysmal AF. This system is designed to improve lesion formation by implementing wide surface area lesions and being conformable to accommodate varying left atrial and pulmonary vein anatomies. It also does not require extensive serial re-positioning any rotation for ablation.

Patients with symptomatic paroxysmal atrial fibrillation who are scheduled to undergo an ablation may qualify for this study.

Peerbridge EF-ACT - AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Using Cor™ ECG Wearable Monitor

The purpose of this research study is to answer specific questions about the accuracy of an artificial intelligence (AI) Software as Medical Device (SaMD) which is intended to compute ejection fraction (EF) severity from ambulatory ECG wearable patch (a patch to be used while walking around). The AI software is used to process previously acquired continuous ECG data produced by the FDA cleared Peerbridge Cor® ECG Wearable Monitor to aid in screening for left ventricle EF severity classification. 

The Peerbridge COR® ECG wearable devices that are being used in this study have been cleared by the United States Food and Drug Administration (FDA). However, the use of the device to estimate EF is considered investigational.

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 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 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 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 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 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 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.
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 SAVIOR - Safety and efficacy of pulmonary vein isolation usi ng pulsed - field ablation (PFA) combined with either PFA - based left atrial posterior wall isolation or Vein of Marshall ethanol ablation in patients with persistent atrial fibrillation

This study will enroll patients who are scheduled to undergo pulsed-field ablation (PFA) procedure to treat persistent AF (PerAF). Pulse field ablation applies ultra-rapid (less than1 second) electrical fields to the heart muscle to cause irreversible electroporation (IRE) to treat AF. This system has been approved in the Europe and by the U.S. Food & Drug Administration (FDA).

Study-participants will be randomly assigned to either pulmonary vein isolation (PVI) + Vein of Marshall (VoM) ablation or PVI+ isolation of left atrial posterior wall (PWI). This study is designed to directly compare the safety and efficacy of PFA-based PVI+PWI vs PFA-based PVI+ VoM alcohol ablation in patients with PersAF.

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).