Clinical trials: sponsored by 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
Hypertension, Renal
RENABLATE-II Feasibility Study of Catheter Based Renal Denervation to Treat Resistant Hypertension - 157
This is a prospective, multi-center, non-randomized, feasibility study to assess the safety and effectiveness of renal artery sympathetic denervation using the investigational devices in subjects with resistant hypertension.
- Trial name
- RENABLATE-II (NCT02095691)
- Testing
- Celsius® ThermoCool® Renal Denervation
- Volunteers
- 19 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
SMART-SF Radiofrequency Ablation Safety Study
This is a prospective safety assessment of the study device during radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial fibrillation (SMART-SF).
- Trial name
- NCT02359890
- Testing
- THERMOCOOL® SMARTTOUCH® (RF ablation treatment)
- Volunteers
- 165 people
- Sponsor
- Biosense Webster, Inc.
Symptomatic Atrial Fibrillation
THERMOCOOL® SMARTTOUCH™ Registry
The primary purpose of this registry is to obtain "real world" clinical use of contact force measurements during ablation procedures.
- Trial name
- NCT01677052
- Volunteers
- 426 people
- Sponsor
- Biosense Webster, Inc.
Arrhythmias
Picasso NAV High-Density Mapping Catheter for Signal Analysis of Complex Arrhythmias - First-In-Man
The primary purpose of the First-In-Man clinical investigation is to assess the Picasso NAV Catheter's ability to collect intracardiac signals within the desired chambers (atrial and/or ventricle) in the heart for the analysis of…
- Trial name
- NCT02110004
- Testing
- Ablation procedure, Picasso NAV Catheter
- Volunteers
- 30 people
- Sponsor
- Biosense Webster, Inc.
Cavotricuspid Isthmus Dependent Right Atrial Flutter
LINEAR II - LME-159 Evaluation of a Multi-Electrode Linear Type Ablation Catheter
The Linear II study is a prospective, single center, non-randomized, interventional feasibility study with the purpose of assessing acute safety of the Multi-Electrode Linear Type Ablation Catheter and the performance of the…
- Trial name
- NCT02257060
- Testing
- Endocardial Ablation
- Volunteers
- 12 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
FLAT Study: First Line Ablation Therapy for Treatment of Paroxysmal Atrial Fibrillation (RAAFT)
The objective of this multicenter randomized study is to establish the effectiveness of treatment for paroxysmal atrial fibrillation (AF), in patients not previously treated with anti-arrhythmic drugs, by encircling the pulmonary…
- Trial name
- NCT00137540
- Testing
- RF ablation, anti-arrhythmic drug therapy
- Volunteers
- 40 people
- Sponsor
- Biosense Webster EMEA
Persistent Atrial Fibrillation
Evaluation of a Multi-electrode Linear Type Catheter (D-1368-01-SI)
The purpose of this trial is to assess acute safety and performance of the Multi-electrode Linear Type Catheter in conjunction with generator software V2.4.0 or above when used for the treatment of Persistent Atrial Fibrillation.
- Trial name
- NCT02991313
- Testing
- Endocardial Ablation Procedure
- Volunteers
- 40 people
- Sponsor
- Biosense Webster, Inc.
Persistent Atrial Fibrillation
FIND CAN Trial: "CF-172"
The purpose of this feasibility study is to further explore characteristics of ablation targets identified by CARTOFINDER 4D LAT Algorithm in subjects with persistent atrial fibrillation and to assess the acute outcome of…
- Trial name
- FIND CAN (NCT03033641)
- Testing
- Ablation procedure
- Volunteers
- 25 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
Efficacy, Safety and Efficiency Study of CARTO® 3 System Guided THERMOCOOL® Catheter Ablation Versus Fluoroscopy Guided Ablation With the Pulmonary Vein Ablation Catheter® (PVAC®)
The purpose of this study is to compare the efficacy, safety and efficiency of CARTO® 3 system guided THERMOCOOL® catheter ablation and fluoroscopy guided Pulmonary Vein Ablation Catheter® (PVAC®) guided ablation for the…
- Trial name
- CLARITY-AF (NCT01116557)
- Testing
- Radiofrequency Ablation procedure
- Volunteers
- 79 people
- Sponsor
- Biosense Webster, Inc.
Cardiac Arrhythmias
Clinical Evaluation of the CARTO™ XP EP Navigation System v9 and Biosense Webster SOUNDSTAR 3D Diagnostic Ultrasound. A Feasibility Study
Feasibility study to evaluate CARTO™ XP EP Navigation System V9 and SOUNDSTAR 3D Diagnostic Ultrasound Catheter.
- Trial name
- NCT00449085
- Testing
- Electrophysiology, CARTO™ XP EP Navigation System V9
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
Evaluation of VISITAG SURPOINT™ Module With External Processing Unit (EPU)
Prospective, non-randomized, post market clinical evaluation of the VISITAG SURPOINT™ Module with External Processing Unit (EPU) when used with STSF catheter and ST catheter compared to an historical control performance goal.
- Trial name
- NCT03624881
- Testing
- Catheter ablation with EPU
- Where
- 41 sites in United States
- Volunteers
- 333 people
- Sponsor
- Biosense Webster, Inc.
Scar-related Atrial Tachycardia, Paroxysmal Atrial Fibrillation
A Study Assessing Arrhythmia Mapping With the Multi-Electrode OPTRELL™ Mapping Catheter
The purpose of this study is to assess the performance and safety for the use of the OPTRELL Catheter for intracardiac mapping in the atria and ventricles.
- Conditions
- Scar-related Atrial Tachycardia, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Tachycardia, Ventricular
- Trial name
- OPTIMUM (NCT04983797)
- Testing
- OPTRELL Mapping Catheter
- Where
- 3 sites in Belgium, Lithuania
- Volunteers
- 31 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation in Subjects With Paroxysmal Atrial Fibrillation
Prospective, non-randomized, pre-market clinical evaluation of the QDOT MICRO™ Catheter to demonstrate the safety and effectiveness when compared to an historical control performance goal.
- Trial name
- Q-FFICIENCY (NCT03775512)
- Testing
- RF Ablation with QDOT Micro
- Where
- 22 sites in United States
- Volunteers
- 283 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
RandOmised Controlled Trial of STAR Mapping™ Guided Ablation for AF.
Atrial fibrillation (AF) is the most common arrhythmia with an expected rise in prevalence over the next decade. Beyond causing troublesome symptoms AF is associated with increased mortality and morbidity.
- Trial name
- ROC-STAR (NCT04442113)
- Testing
- Pulmonary vein isolation plus ablation guided by novel STAR mapping™, Pulmonary vein isolation
- Sponsor
- Rhythm AI Ltd
Persistent Atrial Fibrillation
Repetitive Activation Patterns and Focal Impulses Identification and Ablation in Persistent AF
The primary purpose of this study is to assess the effectiveness of using CARTOFINDER™ maps created by the RHYTHMFINDER-192 catheter and the CARTOFINDER™ Algorithm to terminate persistent atrial fibrillation (PsAF) to either…
- Trial name
- RAPID-AF (NCT03064451)
- Testing
- cartofinder guided ablation followed by PVI
- Where
- 7 sites in Belgium, Canada and 2 more
- Volunteers
- 60 people
- Sponsor
- Biosense Webster, Inc.
Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation CONTINUED ACCESS
This is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the THERMOCOOL® SMARTTOUCH™ catheter.
- Trial name
- NCT01639495
- Testing
- THERMOCOOL® SMARTTOUCH™ Catheter
- Where
- 20 sites in United States
- Volunteers
- 148 people
- Sponsor
- Biosense Webster, Inc.
Heart Diseases, Arrhythmia
NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation
This trial compares the safety and effectiveness of catheter ablation for PAF with antiarrhythmic drug therapy. The investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter.
- Conditions
- Heart Diseases, Arrhythmia, Atrial Fibrillation
- Trial name
- Afib IDE (NCT00116428)
- Testing
- NAVISTAR® THERMOCOOL® Catheter, Antiarrhythmic drug
- Where
- 17 sites in United States, Brazil and 3 more
- Volunteers
- 167 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
Guided Radiofrequency Ablation Using the CARTO® 3 and NavX™ Systems for the Treatment of Paroxysmal Atrial Fibrillation
The purpose of this study is to determine the change in median radiation exposure time and median procedure time following guided radiofrequency (RF) ablation among subjects undergoing treatment for paroxysmal atrial fibrillation…
- Trial name
- CO1 (NCT01036724)
- Testing
- Cardiac Mapping
- Where
- 6 sites in Canada
- Volunteers
- 107 people
- Sponsor
- Biosense Webster, Inc.