Clinical trials: sponsored by Biosense Webster, Inc.
Atrial Fibrillation
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
The main purpose of this clinical study is to investigate the effectiveness workflow of the clinical use of the pulsed field (PF) ablation system (VARIPULSE™ Catheter and TRUPULSE™ Generator) when used for cardiac ablation with…
- Trial name
- VP-CONFIRM (NCT07429214)
- Testing
- Pulsed Field Ablation System
- Where
- 6 sites in Belgium, Denmark and 3 more
- Volunteers
- 42 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
Randomised Comparison of the Octaray and Pentaray Catheters
In this study we aim to compare the mapping performance in the left atrium of the established Pentaray catheter to the newer Octaray catheter.
- Trial name
- COPEC (NCT05988424)
- Testing
- Left atrial mapping
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- University Hospital Southampton NHS Foundation Trust
Atrial Fibrillation
A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAFOUS
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
- PulseSmart (NCT06272981)
- Testing
- Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation
- Where
- 7 sites in Australia, Canada
- Volunteers
- 136 people
- Sponsor
- Biosense Webster, Inc.
Atrial 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 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.
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.
Paroxysmal Atrial Fibrillation
THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index Study
A single-center, real word study of consecutive subjects who undergo radiofrequency ablation for paroxysmal AF using THERMOCOOL SMARTTOUCH®SF (STSF) Catheter guiding by Ablation Index (AI).
- Trial name
- STSF (NCT03963349)
- Where
- China
- Volunteers
- 150 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.
Atrial Fibrillation
A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
The purpose of this study is to demonstrate the safety and 12-month effectiveness of the BWI OMNYPULSE™ pulsed field ablation (PFA) platform for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic…
- Trial name
- OMNY-AF (NCT06455098)
- Testing
- OMNYPULSE™ Catheter with the TRUPULSE Generator
- Where
- 41 sites in United States, Australia
- Volunteers
- 354 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.
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.
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.
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Real-world Experience of Catheter Ablation for the Treatment of Arrhythmias
The primary purpose of this Registry is to assess procedural safety and long-term effectiveness of catheter ablations in the treatment of subjects with PAF, PsAF, and VA.
- Conditions
- Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Ventricular Arrhythmia
- Trial name
- REAL Registry (NCT04088071)
- Testing
- Catheter ablation
- Where
- 75 sites in United States, Canada
- Volunteers
- 20,000 people
- Sponsor
- Heart Rhythm Clinical and Research Solutions, LLC
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.
Paroxysmal AF
Durability of Pulmonary Vein Isolation Using a Variable-Loop Biphasic Pulsed Field Ablation Catheter in Patients With Paroxysmal Atrial Fibrillation
The VARIFY study is designed to find out how durable pulmonary vein isolation (PVI) is after treatment with the VARIPULSE pulsed field ablation (PFA) system in patients with paroxysmal atrial fibrillation (AF).
- Trial name
- VARIFY (NCT07236619)
- Testing
- Pulmonary vein isolation with the VariPulse catheter
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- Erasmus Medical Center
Arrhythmias
Identification for the Treatment of Complex Arrhythmias
The primary purpose of this trial is to demonstrate that the utilization of CartoFinder™ 4D Local Activation Time (LAT) Algorithm may help identify and improve the outcome for the treatment of complex arrhythmias.
- Trial name
- NCT02565069
- Testing
- CartoFinder™ Device with CARTO® 3 System V5 Navigation
- Where
- 4 sites in Belgium, Czechia
- Volunteers
- 70 people
- Sponsor
- Biosense Webster, Inc.
Brugada Syndrome
Epicardial Radiofrequency Catheter Ablation in Patients With Brugada Syndrome
This randomized, sham-controlled, and blinded clinical trial aims to evaluate the effects of radiofrequency catheter ablation on the phenotypic expression of patients with Brugada syndrome.
- Trial name
- NCT05685134
- Testing
- Radiofrequency catheter ablation
- Where
- Brazil
- Volunteers
- 20 people
- Sponsor
- University of Sao Paulo General Hospital
Atrial Fibrillation, Heart Failure With Normal Ejection Fraction
Ablation Versus Medical Management of Atrial Fibrillation in HFpEF
This is a prospective non-blinded randomized control pilot study comparing the effect of pulmonary vein isolation against medical management of atrial fibrillation in patients with Heart Failure with preserved Ejection Fraction…
- Trial name
- AMPERE (NCT04282850)
- Testing
- Pulmonary Vein Isolation
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Inova Health Care Services