About Our Practice

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.

The purpose of this study 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) in patients who are scheduled to undergo cardiac ablation to treat the VT. This new investigational device is designed to ablate the tissue responsible for VT using cryoenergy (freezing), generated from nitrogen circulating in the Adagio VT Cryoablation System to eliminate the abnormal electrical activity.

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.

This study aims to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with reduced HFrEF (heart failure with reduced ejection fraction) . The interatrial shunt, which permits left to right atrial blood flow, reduces symptoms of heart failure. The device utilizes radiofrequency (RF) energy to secure the target tissue.

Eligible subjects will be randomized to either receive the shunt procedure or not. Those who receive the shunt procedure will be followed for 5 years. Subjects in the control group will also have the opportunity to receive the procedure after the last enrolled patient has completed a 12 month post-procedure follow up.

The purpose of this research trial is to learn more about the safety and effectiveness of the investigational ISOLATOR® Synergy Surgical Ablation System in subjects who have been diagnosed with IST.

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

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.

The purpose of this research study is to provide information about the safety and effectiveness of the VARIPULSE™ Catheter and TRUPULSE™ Generator when treating persistent atrial fibrillation (PsAF) compared to commercially available FARAWAVE™ Catheter. It will enroll patients who are scheduled to undergo an ablation for PsAF. Participants will be randomized to undergo an ablation procedure with the VARIPULSE™ Catheter or the FARAWAVE™ Catheter. The VARIPULSE™ Catheter is currently approved for the treatment of paroxysmal atrial fibrillation (PAF) but not persistent atrial fibrillation (PsAF) by the United States Food and DrugAdministration (FDA).

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.

The objective of the study is to evaluate the safety and effectiveness of the FARAFLEX™ Mapping and PFA System combining cardiac mapping and pulsed field ablation (PFA) for the treatment of patients with Paroxysmal atrial fibrillation (PAF) and Persistent atrial fibrillation (PersAF). It will enroll patients who are scheduled to undergo an ablation for PAF or PersAF. 

This investigational study will evaluate the effectiveness of pulse field ablation with Electrographic Flow (EGF)-identified regions outside the pulmonary veins on atrial arrhythmia recurrence. In typical pulse field ablation procedures, the linear lesions of the posterior wall are ablated in addition to the pulmonary veins, such as the roof and mitral isthmus. EGF can be used to identify sources outside the pulmonary veins to identify sources of atrial fibrillation.

Participants will be randomized to either receive standard PVI and posterior wall ablation in the control group, or PVI and EGF-identified ablation as the treatment group. The OptiMap Catheter system will be used to provide EGF-identified regions for ablation.

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

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.

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.

The study involves an investigational device evaluation of the Elite AF Left Atrial Appendage Closure device. The primary objective of this study is to establish the safety and effectiveness for subjects with non-valvular atrial fibrillation with a goal to reduce the risk of stroke.

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).

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.

This study is a prospective, real-world, observational study aimed at understanding acute and long-term product performance, including patient safety, clinical outcomes, and CRT response information associated with the use of the market-released WiSE System in patients with heart failure (HF). It will collect information from enrolled patients who are already schedule to receive the WiSE system. 

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).

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

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.

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.

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.

The purpose of this research is to collect data from patients undergoing a catheter ablation procedure with the VERAFEYE Imaging and Guidance System in order to gain insights into how the system is used, particularly to assess differences in usage among physicians and across hospitals. This data may be used to further develop the VERAFEYE Imaging and Guidance System.

The VERAFEYE Imaging and Guidance System is investigational.

The purpose of this research study is to evaluate the safety and effectiveness of a redo ablation procedure using the Sphere-9™ Catheter and Affera™ Ablation System, along with the Affera™ Mapping System, for the treatment of symptomatic recurrent atrial fibrillation (AF) in patients who have had one previous ablation procedure.

The Sphere-9 Catheter is approved by the U.S. Food and Drug Administration (FDA) for use in cardiac ablation for the treatment of persistent AF. For this study, the Sphere-9 Catheter will be used to treat both persistent AF as well as paroxysmal AF.

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).

The purpose of this investigational study is to demonstrate the safety and effectiveness of the Sphere-360 and Affera mapping and ablation system for treating paroxysmal atrial fibrillation (PAF). The flexible catheter design also gives it the capability to treat varying cardiac anatomies.

A subset of participants will receive pre- and post- procedural magnetic resonance imaging (MRI) to evaluate the incidence of silent cerebral lesions and events after their procedure.

This study assesses the safety and performance of the Sphere-9™ Catheter and Affera Ablation System for the treatment of ventricular tachycardia (VT) in patients with recurrent, sustained, scar-related monomorphic VT (MMVT). The study will enroll patients who are scheduled to undergo ablation to treat MMVT.

The Sphere-9 Catheter and Affera Ablation System being used in this study are investigational because they have not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of VT. The Affera Mapping System is approved by the FDA and will be used according to its commercial indication.The Affera Mapping System may have investigational software installed only for ablation procedures in this study, and will only be considered investigational while investigational software is installed.

The purpose of this study is to demonstrate the safety and effectiveness of the Sphere-9 Catheter and Affera Ablation System for the treatment of ventricular tachycardia (VT). It will enroll patients who have been scheduled to undergo ablation for treatment of recurring abnormal heartbeat called monomorphic ventricular tachycardia (VT).

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). 

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.

This research study will collect electrical recordings that are very similar to those that are part of a routine electrophysiological study (EPS). No experimental catheters, equipment nor medications will be used. It will enroll patients who are scheduled to undergo an EPS and repeat ablation to treat atrial fibrillation (AF). The electrical recordings used for the study will be transferred to a separate software tool. The objective of this observational study is to evaluate if the research software can identify direction of electrical conduction in the heart.

This study will evaluate theCellFX® nsPFA™ Cardiac Catheter System (CellFX System) for the treatment of atrial fibrillation (AF). It will enroll patients who have been diagnosed with AF and are scheduled to undergo an ablation for treatment of AF. The CellFX System is intended to treat AF that has not responded to medication by delivering a new type of energy called nanosecond pulsed field ablation (nsPFA). \

The CellFX System is investigational and does not have regulatory approval (this means it has not been approved by the U.S. Food and Drug Administration [FDA]).

This study will enroll patients to participate in this study who are scheduled to receive a Left Atrial AppendageOcclusion (LAAO) device. During this procedure, doctors routinely use ICE catheters and machines made by Siemens, and are now investigating a series of “next-generation” ICE catheters which have a greater number of transducers which are designed to improve image quality and procedural guidance.

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.

This study will enroll patients who are scheduled to undergo left atrial appendage (LAA) occlusion via the Watchman FLX device. Although unlikely (<1%), thrombus can still form on the surface of the device during the very first months after Watchman implantation. Two pharmacological strategies have been tested to prevent this complication, such as antiplatelet therapy including Aspirin monotherapy (ASA) or novel OAC at half dose (hdNOAC). The purpose of this study is to provide insights into the efficacy and safety of ASA versus hdNOAC after Watchman FLX implantation.

Participants will wear the Skiin chest band and collect their ECG for 14 days. They will also record any symptoms they experience during the monitoring period, such as palpitations, shortness of breath, and fatigue. The data collected in this study will be used to develop new algorithms and patient monitoring tools to detect and predict cardiovascular health problems.

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.