Clinical trials: sponsored by Biosense Webster, Inc.
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter
The purpose of this study is to assess the performance and safety of using the investigational catheter.
- Conditions
- Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Ventricular Tachycardia
- Trial name
- NCT05970120
- Testing
- NUVISION NAV Ultrasound Catheter
- Where
- 3 sites in Croatia, Israel and 1 more
- Volunteers
- 30 people
- Sponsor
- Biosense Webster, Inc.
Syncope, Neurogenic, Syncope
Efficacy of a Right-sided Ablation of the Anterior Ganglionated Plexus for Neurally Mediated Syncope
The third study on CardNM (CardNMH3 study) is a multicenter, double-blind, randomized trial with a sham control group investigating the efficacy and safety of a computed tomography (CT)-guided, right-sided ablation of the…
- Trial name
- CardNMH3 (NCT04755101)
- Testing
- EPS, electro-anatomical mapping, ARGP ablation, and pharmacological evaluation., EPS, electro-anatomical mapping, and pharmacological evaluation.
- Where
- 3 sites in Belgium
- Volunteers
- 110 people
- Sponsor
- Imelda Hospital, Bonheiden
Non-ischemic Cardiomyopathy
Electrogram-Guided Myocardial Advanced Phenotyping
Fluoroscopy guided EMB and EAM guided EMB on all patients meeting existing guidelines for biopsy.
- Trial name
- eMAP (NCT03293381)
- Testing
- additional biopsies
- Where
- 2 sites in United States
- Volunteers
- 35 people
- Sponsor
- University of Pennsylvania
Ventricular Tachycardia
The TRAMPOLINE VT Study
This non-randomised, prospective trial will examine the feasibility and efficacy of VT ablation guided by activation mapping using the Octaray and Optrell catheters.
- Trial name
- NCT05152784
- Testing
- Octaray catheter, Standard of care
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Barts & The London NHS Trust
Stroke
WAveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2
The WAVECREST 2 trial is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate the safety and effectiveness of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System.
- Trial name
- WAVECREST2 (NCT03302494)
- Testing
- Coherex WaveCrest® Left Atrial Appendage Occlusion System, Watchman® LAA Closure Device
- Where
- 25 sites in United States, Australia
- Volunteers
- 248 people
- Sponsor
- Coherex Medical
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
A Study Assessing Arrhythmia Mapping With a Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter
The purpose of this study is to assess the performance and safety for the use of the investigational catheter for intracardiac mapping in the atria and ventricles.
- Conditions
- Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Ventricular Tachycardia
- Trial name
- COSMOS (NCT05373862)
- Testing
- Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter
- Where
- 4 sites in Belgium, Croatia and 1 more
- Volunteers
- 40 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
A Comparison of Antiarrhythmic Drug Therapy and Radio Frequency Catheter Ablation in Patients With Paroxysmal Atrial Fibrillation
The purpose of this study is to compare radiofrequency catheter ablation and antiarrhythmic drug treatment for the maintenance of sinus rhythm in paroxysmal atrial fibrillation patients.
- Trial name
- NCT00540787
- Testing
- Radiofrequency ablation, antiarrhythmic drugs, Amiodarone, flecainide, propafenone, quinidine, dofetilide, sotalol, cibenzoline, beta blocking and calcium channel blocking agents and antiarrhythmic drugs, ThermoCool Radiofrequency Catheter
- Where
- 6 sites in United States, France and 1 more
- Volunteers
- 112 people
- Sponsor
- Biosense Webster, Inc.
Hypertension, Renal
RENABLATE Feasibility Study CS156 (EC12-02) Study of Catheter Based Renal Denervation to Treat Resistant Hypertension
The RENABLATE feasibility study is a prospective, multi-center, non-randomized feasibility study to evaluate the safety and effectiveness of the investigational multi-electrode ablation catheter and integrated ablation system to…
- Trial name
- NCT01756300
- Testing
- Celsius® ThermoCool® RD
- Volunteers
- 35 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
Oral Anticoagulation Therapy Pilot Study
The objective of this study is to determine the safety of discontinuing oral anticoagulation therapy in high risk patients who have had a successful cardiac ablation and remain AF recurrence free for 3 months post ablation.
- Trial name
- OAT (NCT01959425)
- Testing
- Off OAT Group (Test), On OAT Group (Control)
- Volunteers
- 80 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
Exploratory Safety and Effectiveness Evaluation of Pulsed Field Ablation (PFA) by Balloon Catheter With TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF)
The purpose of this study is to explore preliminary safety and acute effectiveness of pulsed field ablation by the ablation system (pulsed field ablation balloon catheter and TRUPULSE generator) when used for isolation of the…
- Trial name
- ZephIRE (NCT06495216)
- Testing
- Pulsed Field Ablation by a Balloon Catheter with the TRUPULSE Generator
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
NAVISTAR® THERMOCOOL® Catheter Post Approval Registry
The purpose of this registry is to provide additional corroborative short-term safety and long-term safety data for the NAVISTAR THERMOCOOL and NAVISTAR EZ STEER THERMOCOOL catheters in the treatment of symptomatic Paroxysmal…
- Trial name
- AF Registry (NCT00964392)
- Testing
- Atrial fibrillation ablation
- Volunteers
- 437 people
- Sponsor
- Biosense Webster, Inc.
Ventricular Tachycardia
Catheter Evaluation for Endocardial Ablation in Patients With Ventricular Tachycardia
The primary objective is to provide additional corroborative safety and efficacy data for the Navistar ThermoCool catheter for the treatment of subjects with ischemic Ventricular Tachycardia.
- Trial name
- VT-CoA (NCT00412607)
- Testing
- NAVISTAR® THERMOCOOL® Catheter
- Volunteers
- 249 people
- Sponsor
- Biosense Webster, Inc.
Heart Diseases, Arrhythmia
NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation- Treatment Use Study
This trial evaluates the safety and effectiveness of catheter ablation for PAF. The investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter.
- Conditions
- Heart Diseases, Arrhythmia, Atrial Fibrillation
- Trial name
- AFTX (NCT00721149)
- Testing
- Radiofrequency Ablation
- Volunteers
- 10 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
SMART China, A Multi-center Clinical Registry Study
This is a prospective effectiveness and safety assessment of the study device during radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial fibrillation.
- Trial name
- NCT02485925
- Testing
- THERMOCOOL® SMARTTOUCH™
- Volunteers
- 200 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
Safety and Effectiveness of STSF Catheter Evaluated for Treating Symptomatic Persistent Atrial Fibrillation (PsAF)
This is a prospective, multicenter, non-randomized clinical evaluation utilizing the THERMOCOOL SMARTTOUCH® SF catheter compared to a predetermined performance goal.
- Trial name
- PRECEPT (NCT02817776)
- Testing
- THERMOCOOL SMARTTOUCH® SF catheter
- Volunteers
- 381 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation
To demonstrate safety and effectiveness of nMARQ Catheter System [nMARQ] compared with THERMOCOOL® Navigational Family of catheters in treating subjects with drug-refractory symptomatic paroxysmal atrial fibrillation (PAF).
- Trial name
- NCT01824394
- Testing
- nMARQ Navigation Catheters, NaviStar ThermoCool Catheters
- Volunteers
- 481 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
Atrial Fibrillation Progression Trial
The objective of this study is to determine whether early radiofrequency (RF) ablation treatment, using the CARTO® 3 or CARTO® XP System, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™) in…
- Trial name
- ATTEST (NCT01570361)
- Testing
- Catheter Ablation, Drug Treatment
- Volunteers
- 255 people
- Sponsor
- Biosense Webster, Inc.
Heart Diseases, Arrhythmia
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
The purpose of this study is to demonstrate the safety and effectiveness of the THERMOCOOL® SMARTTOUCH™ Catheters with Contact Force Sensing Capability in the treatment of drug refractory symptomatic paroxysmal Atrial…
- Conditions
- Heart Diseases, Arrhythmia, Atrial Fibrillation
- Trial name
- NCT01385202
- Testing
- THERMOCOOL® SMARTTOUCH™ Catheter
- Volunteers
- 172 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
Clinical Study for Workflow and Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System for Treating Symptomatic Paroxysmal AF (QDOT-Micro)
The QDOT-Micro study is a prospective, multi-center, non-randomized, interventional clinical study.
- Trial name
- NCT02944968
- Testing
- THERMOCOOL SMARTTOUCH® SF-5D catheter
- Volunteers
- 51 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
CACAF2 Study: Catheter Ablation for Cure of Atrial Fibrillation
The objective of this prospective multicenter randomized study is to establish the effectiveness of treatment of persistent atrial fibrillation by encircling the pulmonary veins with radiofrequency (RF) ablation and creating…
- Trial name
- CACAF-2 (NCT00227344)
- Testing
- RF ablation, Antiarrhythmic drugs
- Volunteers
- 129 people
- Sponsor
- Biosense Webster EMEA