About Our Practice
Abbott CATALYST - Clinical trial of atrial fibrillation patients comparing left atrial appendage occlusion therapy to non-vitamin K antagonist oral anticoagulants
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.
AFFERA Sphere-9 - Treatment of Persistent Atrial Fibrillation with the Sphere-9™ Mapping and Ablation Catheter and the Affera Mapping and Ablation System
This study is currently in follow-up only and is not enrolling new patients.
Atricure HEAL-IST IDE Trial - Hybrid Epicardial and Endocardial Sinus-Node SpAring AbLation Therapy for Inappropriate Sinus Tachycardia
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
Attune Medical - Improving Oesophageal Protection During Atrial Fibrillation (AF) Ablation: A Multicentre Study
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 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)
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
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 is observational and will collect and analyze clinical information on patients who receive the WATCHMAN FLX™ Pro device.
Cleveland Clinic WATCH RWE - WATCHMAN FLX Real World Evidence
CVRx BATwire Implant Kit Study
Impulse Dynamics AIM - Assessment of Implantable CCM in the Heart Failure Group with Higher Ejection Fraction
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
Impulse Dynamics OPTIMIZER Smart Post-Approval Study
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.
MARVEN - Clinical, Electrocardiographic, and Cardiac Magnetic Resonance Imaging Risk Factors Associated with Ventricular Tachyarrhythmias in Nonischemic Cardiomyopathy
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 Crome/Cobalt Respiration Study
This study will involve the use of an Investigational Software Application on a laptop, which will be used to enable (turn on) an investigational feature that already exists on the subject’s device. This investigational feature is called the Sensor Research Holter Mode (SRHM) feature and allows for additional data collection from the implanted device.
The purpose of this study is to compare respiration measures derived from the Crome and Cobalt ICD and CRT-D SureScan™ devices using the mHolter recorder against the gold standard of capnography (carbon dioxide monitoring) during the course of different use conditions, such as body position, exercise activities, and pacing rate. Being able to measure respiratory rates from an implantable device while the patient goes about their everyday life could help doctors monitor patients more effectively outside of the clinic setting.
Medtronic Cryo AF Global Registry - STOP Persistent
Medtronic LEADR - Lead Evaluation for Defibrillation and Reliability
This study is currently in follow-up only and is not enrolling new patients.
Medtronic Product Surveillance Registry
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.
St. Jude AMULET - Amplatzer Amulet Left Atrial Appendage Occluder Randomized Controlled Trial
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
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
TCAI GSAF - Association of Genetic Variants with Risk of Stroke in Patients with Atrial Fibrillation Off Anticoagulation
TCAI hdNOAC - Efficacy of Different Anti-Thrombotic Strategies After Percutaneous Left Atrial Appendage Occlusion (LAAO)
TCAI IVTCC: An International VT Ablation Center Collaborative Group: Multi-center Ventricular Tachycardia Catheter Ablation Registry
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
TCAI PLATINUM - Impact of post-ablation alcohol intake on arrhythmia recurrence, quality of life and cognition in patients with atrial fibrillation
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.