Clinical trials: sponsored by Biosense Webster, Inc.
Atypical Atrial Flutter, Atrial Flutter
Pulsed-Field Ablation for Recurrent Atypical Atrial Flutter
Recurrent atypical atrial flutter (AFL) after prior atrial fibrillation or flutter ablation remains challenging to treat, and conventional radiofrequency ablation may be limited by incomplete lesion formation and risk of…
- Trial name
- NCT07362134
- Testing
- Point-by-point pulsed-field catheter ablation
- Where
- Taiwan
- Volunteers
- 30 people
- Sponsor
- Taipei Veterans General Hospital, Taiwan
Chagas Cardiomyopathy, Ventricular Arrythmia
Sympathetic Denervation by Video-assisted Thoracoscopy in Control of Cardiac Arrhythmias in Patients With Chagas Disease
Ventricular tachycardia (VT) is the main cause of sudden death in patients with structural heart diseases. The use of ICD (implantable cardio-defibrillator) could prevent sudden death, however, the occurrence of repetitive shock…
- Trial name
- NCT04239144
- Testing
- Bilateral sympathectomy, Catheter ablation
- Where
- Brazil
- Volunteers
- 45 people
- Sponsor
- University of Sao Paulo General Hospital
Atrial Fibrillation (AF)
A Prospective Observational Study Evaluating the Incidence of Silent Cerebral Lesions and Procedural Safety Following Atrial Fibrillation Ablation Using the VARIPULSE™ Pulsed Field Ablation System
Study Type: Observational Study Goal: The goal of this study is to evaluate the incidence and burden of silent cerebral lesions (SCLs) detected on brain magnetic resonance imaging (MRI) after pulsed field ablation (PFA) for…
- Trial name
- VARIACE (NCT07363278)
- Where
- South Korea
- Volunteers
- 40 people
- Sponsor
- Seoul National University Hospital
Drug Refractory Paroxysmal Atrial Fibrillation
A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAF
The purpose of this study is to demonstrate safety and effectiveness of the Biosense Webster (BWI) ablation system (THERMOCOOL SMARTTOUCH surround flow [STSF] catheter and TRUPULSE generator) when used for isolation of the atrial…
- Trial name
- SMARTPULSE PAF (NCT06144632)
- Testing
- THERMOCOOL STSF Bi- Directional Navigation Catheter, TRUPULSE Generator
- Where
- 29 sites in United States
- Volunteers
- 237 people
- Sponsor
- Biosense Webster, Inc.
Refractory Paroxysmal Atrial Fibrillation
A Study of Multi-electrode Circular Irreversible Electroporation (IRE) Catheter and Multi-Channel IRE Generator in Paroxysmal Atrial Fibrillation (AF)
The purpose of this study is to evaluate the long term off-Antiarrhythmic Drug (AAD) effectiveness of Biosense Webster, Inc. Irreversible Electroporation (BWI IRE) system in treatment of participants with symptomatic drug…
- Trial name
- AFIRE (NCT05552963)
- Testing
- Multi-Channel Irreversible Electroporation (IRE) Generator, Multi-Channel Circular IRE Catheter
- Where
- 6 sites in China
- Volunteers
- 142 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation (AF)
Left Atrial Posterior Wall and Mitral Isthmus PF Ablation in Non-Paroxysmal AF Patients
An observational study evaluating efficacy and safety of the Varipulse catheter in pulsed-field ablation of atrial fibrillation
- Trial name
- NCT06801392
- Testing
- pulsed-field ablation
- Where
- Czechia
- Volunteers
- 50 people
- Sponsor
- Charles University, Czech Republic
Paroxysmal Atrial Fibrillation (PAF)
Real-world Safety and Effectiveness Registry of Catheter Ablation of Paroxysmal Atrial Fibrillation as Initial Control Therapy With the Thermocool SmartTouch SF Catheter (A Sub-study of REAL AF Registry)
To generate real-world evidence from the parent study, REAL AF registry, on the use of Thermocool SmartTouch SF (STSF) catheter in ablation for the treatment of paroxysmal atrial fibrillation (PAF).
- Trial name
- First Line (NCT07092774)
- Testing
- Ablation
- Where
- 12 sites in United States
- Volunteers
- 344 people
- Sponsor
- Heart Rhythm Clinical and Research Solutions, LLC
Paroxysmal Atrial Fibrillation
The Long-term Safety and Effectiveness Evaluation of the QDOT MICRO System Use in Conjunction With VISITAG SURPOINT Module for the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation.
Observational, multi-center, non-randomized, post-market study. This is a nested sub-study of the REAL AF Registry. Consecutive symptomatic drug refractory paroxysmal atrial fibrillation (PAF) patients from the registry will be…
- Trial name
- QDOT PAS (NCT06324201)
- Testing
- Ablation Procedure
- Where
- 21 sites in United States
- Volunteers
- 250 people
- Sponsor
- Heart Rhythm Clinical and Research Solutions, LLC
Atrial Fibrillation Paroxysmal
Esophageal Temperature During PVI Using Q-DOT Micro
This study will assess how two different ablation strategies, using two different ablation catheters during catheter ablation for paroxysmal atrial fibrillation, affect the temperature of the esophagus during ablation, and the…
- Trial name
- NCT06392932
- Testing
- QDOT Micro ablation catheter, ST SF ablation catheter
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Cedars-Sinai Medical Center
Atrial Fibrillation
Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
The primary objective of this clinical investigation is to demonstrate safety and effectiveness of the Multi-Electrode RF Balloon catheter for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation.
- Trial name
- STELLAR (NCT03683030)
- Testing
- Multi-Electrode RF Balloon Catheter
- Where
- 41 sites in United States, China and 1 more
- Volunteers
- 397 people
- Sponsor
- Biosense Webster, Inc.
Ventricular Tachycardia, Ischemic Cardiomyopathy
Ablation-Index Guided Scar-Mediated Ventricular Tachycardia Ablation in Patients With Ischemic Cardiomyopathy
Over the last decade, radiofrequency catheter ablation (RFCA) has become an established treatment for ventricular arrhythmias (VA).
- Trial name
- AIM-VT (NCT06138873)
- Testing
- Ablation-index guided ventricular tachycardia ablation, Ventricular tachycardia ablation with no AI-guidance
- Where
- 5 sites in United States
- Volunteers
- 100 people
- Sponsor
- Rush University Medical Center
Atrial Fibrillation (AF), Paroxysmal AF
Evaluation of the Impact of Pulsed Field Ablation on Autonomic Nervous System Modulation in Paroxysmal Atrial Fibrillation
The objective of this clinical trial is to evaluate the impact of pulse field (PF) energy, both alone and in combination with radiofrequency (RF) energy, on vagal modulation during point-by-point pulmonary vein isolation (PVI) in…
- Trial name
- GPfIRE (NCT06647485)
- Testing
- PF-only PVI, Hybrid PVI, RF-only PVI
- Where
- Belgium
- Volunteers
- 105 people
- Sponsor
- VZW Cardiovascular Research Center Aalst
Atrial Fibrillation
A Study For Treatment Of Paroxysmal Atrial Fibrillation (PAF) With The THERMOCOOL SMARTTOUCH SF Catheter and TRUPULSE Generator
The purpose of this study is to demonstrate safety and effectiveness of the ablation system (THERMOCOOL SMARTTOUCH SF [STSF] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in…
- Trial name
- SmartfIRE (NCT05752487)
- Testing
- Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation
- Where
- 9 sites in Austria, Belgium and 2 more
- Volunteers
- 149 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation.
The QDOT-FAST study is a prospective, multi-center, non-randomized, interventional clinical study.
- Trial name
- QDOT-FAST (NCT03459196)
- Testing
- THERMOCOOL SMARTTOUCH SF-5D Catheter
- Where
- 7 sites in Austria, Belgium and 2 more
- Volunteers
- 54 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins.
This clinical investigation is a prospective, multicenter, single arm clinical evaluation utilizing the multi-electrode radiofrequency balloon catheter and the multi-electrode circular diagnostic catheter.
- Trial name
- SHINE (NCT03437733)
- Testing
- Radiofrequency Ablation
- Where
- 5 sites in Czechia, Italy and 1 more
- Volunteers
- 98 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
Performance of QDOT Micro™ Catheter With nGEN Generator for Patients With AFIB.
This workflow study will further evaluate the acute performance and safety of the QDOT MICRO™ catheter in a clinical setting used in combination with nGEN Generator. Subjects will be followed for 7 days post procedure.
- Trial name
- NCT04545619
- Testing
- QDOT MICRO System
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
Evaluation of Ablation Index and VISITAG™ (ABI-173)
The purpose of this study is to assess the safety, acute and long term effectiveness, during standard RF ablation procedures while using Ablation Index and VISITAG™ software in combination with a Thermocool SmartTouch® (ST) or…
- Trial name
- VISTAX (NCT03062046)
- Testing
- RF ablation
- Where
- 17 sites in Austria, Belgium and 7 more
- Volunteers
- 340 people
- Sponsor
- Biosense Webster, Inc.
Congestive Heart Failure, Left Ventricular Failure
Catheter Ablation vs. Medical Therapy in Congested Hearts With AF
This study is a multi-center, randomized, unblinded, clinical trial. The objective is to determine if catheter-based atrial fibrillation (AF) ablation is superior to medical treatment in patients with impaired left ventricular…
- Conditions
- Congestive Heart Failure, Left Ventricular Failure, Atrial Fibrillation
- Trial name
- CATCH-AF (NCT02686749)
- Testing
- Catheter Ablation, FDA approved anti arrhythmic drug
- Where
- 6 sites in United States
- Volunteers
- 4 people
- Sponsor
- The Cleveland Clinic
Atrial Fibrillation
A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE)
The primary objective is to demonstrate safety and long-term effectiveness of the irreversible electroporation (IRE) system (Circular IRE Catheter and IRE Generator) when used for isolation of the atrial pulmonary veins (PVs) in…
- Trial name
- inspIRE (NCT04524364)
- Testing
- Pulsed Field Ablation (PFA) Therapy
- Where
- 13 sites in Austria, Belgium and 6 more
- Volunteers
- 272 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System
To demonstrate the safety and 12-month effectiveness of the VARIPULSE™ Catheter when used in conjunction with the TRUPULSE™ Generator for pulmonary vein isolation (PVI) in the treatment of subjects with symptomatic paroxysmal…
- Trial name
- AdmIRE (NCT05293639)
- Testing
- Pulse Field Ablation
- Where
- 30 sites in United States
- Volunteers
- 362 people
- Sponsor
- Biosense Webster, Inc.