Pharmaceutical sponsor
Biosense Webster, Inc. Clinical Trials
Studies where Biosense Webster, Inc. is the lead sponsor: its pipeline by phase, what is enrolling now and where. Studies it supports as a collaborator are in the search.
In numbers
Open to volunteers: recruiting, not yet recruiting or enrolling by invitation. Active adds studies under way that have stopped recruiting.
Open to volunteers
All 9Atrial Fibrillation
A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System
The purpose of this study is to evaluate the long-term safety and effectiveness of the FDA approved VARIPULSE catheter system for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial…
- Trial name
- AdmIREPAS (NCT07227532)
- Testing
- Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator
- Where
- 23 sites in United States
- Volunteers
- 276 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With TRUPULSE™ Generator in Persistent Atrial Fibrillation
This purpose of this study is to understand how safe Biosense Webster Pulsed Field (PF)/Radiofrequency (RF) ablation system is and how well it works over 12 months in participants with persistent atrial fibrillation (PsAF…
- Trial name
- DualSmart (NCT07845682)
- Testing
- Radiofrequency/Pulsed Field Ablation
- Volunteers
- 150 people
- Sponsor
- Biosense Webster, Inc.
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
The purpose of this study is to assess the safety and feasibility of the investigational catheter for mapping the atrial and ventricular regions of the heart.
- Conditions
- Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Ventricular Tachycardia
- Trial name
- FEATHER (NCT07116525)
- Testing
- Paddle-Shaped, High-Density, Multi-Electrode Mapping Catheter
- Where
- 5 sites in Belgium, France and 1 more
- Volunteers
- 90 people
- Sponsor
- Biosense Webster, Inc.
Arrhythmias, Cardiac
An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac Arrhythmias
The purpose of this study is to prospectively collect clinical data evaluating the ongoing safety and performance during routine-use standard cardiac arrhythmia mapping and/or ablation procedures while using commercial Biosense…
- Trial name
- SECURE (NCT04750798)
- Testing
- BWI Medical Device, Varipulse Catheter, Dual Energy THERMOCOOL SMARTTOUCH SF Catheter
- Where
- 46 sites in Austria, Belgium and 13 more
- Volunteers
- 8,000 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE PRO Software in Participants With PsAF
The main purpose of this study is to investigate the workflow of the clinical use of the pulsed field (PF) ablation system (VARIPULSE catheter and TRUPULSE generator) when used for cardiac ablation with the new VARIPULSE Pro…
- Trial name
- VP-EXTRA (NCT07428564)
- Testing
- Pulsed Field Ablation System
- Where
- 6 sites in Belgium, Denmark and 3 more
- Volunteers
- 50 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior Vena Cava Isolation
The purpose of this study is to assess how safe VARIPULSE catheter system is for treatment of a heart rhythm disease called persistent atrial fibrillation (PsAF) in participants who are having a catheter ablation procedure (treat…
- Trial name
- SPAA PFA (NCT07527299)
- Testing
- VARIPULSE Catheter System, LAAO Device
- Where
- 11 sites in United States
- Volunteers
- 1,070 people
- Sponsor
- Biosense Webster, Inc.
Arrhythmias, Cardiac
A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias
The purpose of this study is to collect information about how safe Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) catheter with TRUPULSE™ Generator is and how effective a specific procedural workflow is when this ablation system…
- Trial name
- DEVA (NCT07727057)
- Testing
- Radiofrequency/Pulsed Field Ablation System
- Where
- 4 sites in Austria, Belgium and 1 more
- Volunteers
- 90 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation
The purpose of this study is to assess how safe VARIPULSE pulsed field ablation (PFA) catheter is and how well it works compared to food and drug administration (FDA) approved FARAWAVE PFA catheter in participants with…
- Trial name
- PERSIGMA RCT (NCT07523750)
- Testing
- VARIPULSE Catheter, FARAWAVE Catheter
- Where
- 10 sites in United States
- Volunteers
- 566 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
A Study to Predict Atrial Fibrillation (AF) Burden in Participants With PAF and PsAF Treated With the VARIPULSE™ PFA Catheter
The purpose of this study is to evaluate how safe VARIPULSE™ Catheter is and how well it works in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and…
- Trial name
- SPECTRA-AF (NCT07788989)
- Testing
- VARIPULSE Catheter System (PVI), VARIPULSE Catheter System (PVI and PWI)
- Where
- United States
- Volunteers
- 2,300 people
- Sponsor
- Biosense Webster, Inc.
Completed, with results posted
All –Atrial Fibrillation
A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator
The purpose of this study is to demonstrate safety and effectiveness of the ablation system (OMNYPULSE Bi-directional catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of…
- Trial name
- Omny-IRE (NCT05971693)
- Testing
- OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator
- Where
- 13 sites in Belgium, Canada and 6 more
- Volunteers
- 188 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
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.
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
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.