Cardiac Ablation Clinical Trials

Clinical trials related to Cardiac Ablation Procedure

Workflow Study of the VARIPULSE™ Catheter With the TRUPULSE™ Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF) or Persistent Atrial Fibrillation (PsAF) With the New VARIPULSE™ Pro Software

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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 software in participants with paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and stop on their own, usually within seven days, often resolving within 24-48 hours, though sometimes lasting up to a week) and persistent atrial fibrillation (PsAF; irregular, rapid heartbeat that lasts over 7 days and doesn't stop on its own).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Diagnosed with symptomatic persistent atrial fibrillation (PsAF) or paroxysmal atrial fibrillation (PAF)

• Selected to undergo an ablation procedure for management of their arrhythmia by pulmonary vein isolation (PVI) only or PVI only with cavotricuspid isthmus (CTI) dependent atrial flutter ablation

• Failed at least one antiarrhythmic drug (AAD; class I to IV) as evidenced by recurrent symptomatic atrial fibrillation (AF), or intolerable or contraindicated to the AAD

• Age 18-75 years

• Willing and capable of providing consent

• Able and willing to comply with all pre-, post- and follow-up testing and requirements

Locations
Other Locations
Belgium
AZORG campus Aalst Moorselbaan
NOT_YET_RECRUITING
Aalst
A.Z. Sint Jan
NOT_YET_RECRUITING
Bruges
Denmark
Aarhus University Hospital
NOT_YET_RECRUITING
Aarhus N
France
Hospices Civils de Lyon HCL
NOT_YET_RECRUITING
Bron
Institut Medico chirurgical Montsouris
NOT_YET_RECRUITING
Paris
Germany
University Hospital of the Ruhr-University of Bochum
NOT_YET_RECRUITING
Bad Oeynhausen
Italy
Azienda Ospedaliera Universitaria 'Policlinico Tor Vergata'
NOT_YET_RECRUITING
Roma
IRCCS Policlinico San Donato
NOT_YET_RECRUITING
San Donato Milanese
Lithuania
Vilnius University Hospital Santaros Clinics
RECRUITING
Vilnius
Netherlands
Erasmus MC
NOT_YET_RECRUITING
Rotterdam
Contact Information
Primary
Nathalie Macours
nmacours1@its.jnj.com
+32 2 746 30 76
Time Frame
Start Date: 2026-03-23
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 50
Treatments
Experimental: Pulsed Field Ablation: VARIPULSE Catheter with TRUPULSE Generator and VARIPULSE Pro Software
Participants undergoing cardiac ablation for management of treatment of symptomatic Persistent Atrial Fibrillation (PsAF) or Paroxysmal Atrial Fibrillation (PAF) will undergo pulsed field ablation (PFA) with the VARIPULSE Catheter and the TRUPULSE Generator with the new VARIPULSE Pro software.
Related Therapeutic Areas
Sponsors
Leads: Biosense Webster, Inc.

This content was sourced from clinicaltrials.gov