About Our Practice

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. 

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.

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. 

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.

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.

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.

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

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.

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. 

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 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.

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%.

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 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. 

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. 

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).

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.

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.

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.

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 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.

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.

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.

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.

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.

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. 

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. 

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). 

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.

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. 

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.