A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Biosense Webster, Inc.
Study ID
NCT07523750
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • VARIPULSE Catheter — DEVICE
    Pulsed Field Ablation using the VARIPULSE catheter.
  • FARAWAVE Catheter — DEVICE
    Pulsed field ablation using the FARAWAVE catheter.

Study Details

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 symptomatic persistent atrial fibrillation (PsAF; continuous irregular, rapid heartbeat that lasts over 7 days and doesn't stop on its own).

Key Dates

First listed
Apr 13, 2026
Start date
Apr 2, 2026
Status verified
Aug 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
566 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: VARIPULSE Pulsed Field Ablation (PFA) Catheter
    Participants with persistent atrial fibrillation (PsAF) undergoing catheter ablation will undergo the ablation procedure with VARIPULSE catheter, and will be followed for up to 12 months post procedure.
  • Active Comparator: FARAWAVE PFA Catheter
    Participants with PsAF undergoing catheter ablation will undergo the ablation procedure with FARAWAVE catheter, and will be followed for up to 12 months post procedure.

Primary Outcome Measure

Occurrence of Early Onset Primary Adverse Events (PAEs) [ Time Frame: Up to 7 days post-index procedure ]

Central Contacts

Locations (30)

FacilityCityStateZIPSite coordinators
Arizona Arrhythmia Research CenterPhoenixArizona85016-
Arrhythmia Research GroupJonesboroArkansas72401-
OC Medical CenterFountain ValleyCalifornia92708-
Stanford University Medical CenterStanfordCalifornia94305-
Community Memorial HospitalVenturaCalifornia93003-
St. Vincents Medical CenterJacksonvilleFlorida32204-
HCA Florida Mercy HospitalMiamiFlorida33133-
NCH HealthcareNaplesFlorida34102-
Emory Saint Joseph's HospitalAtlantaGeorgia30342-
Memorial Health University Medical CenterSavannahGeorgia31404-
Endeavor Health Glenbrook HospitalGlenviewIllinois60026-
Advocate Christ Medical CenterOak LawnIllinois60453-
The Kansas City Heart Rhythm InstituteOverland ParkKansas662111-
Baptist Health LexingtonLexingtonKentucky40503-
Tulane University Heart & Vascular InstituteNew OrleansLouisiana70112-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Corewell Health William Beaumont University HospitalRoyal OakMichigan48073-
Trinity Health Michigan Heart - Ann Arbor CampusYpsilantiMichigan48197-
Mayo Clinic RochesterRochesterMinnesota55905-
Rutgers Robert Wood Johnson Medical SchoolNew BrunswickNew Jersey08901-
Lenox Hill HospitalNew YorkNew York10075-
Rochester General HospitalRochesterNew York14621-
Montefiore Medical CenterThe BronxNew York10467-
WakeMed HospitalRaleighNorth Carolina27610-
York HospitalYorkPennsylvania17403-3676-
Texas Cardiac Arrhythmia Research FoundationAustinTexas78705-
Baylor Research InstitutePlanoTexas75093-
Intermountain Medical CenterMurrayUtah84107-
University of Wisconsin At MadisonMadisonWisconsin53792-

Find similar trials in Phoenix, AZ

Nationwide
Atrial fibrillation trialsCardiology trialsHeart disease trials
By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
Arizona Arrhythmia Research Center· Phoenix, AZArrhythmia Research Group· Jonesboro, AROC Medical Center· Fountain Valley, CAStanford University Medical Center· Stanford, CACommunity Memorial Hospital· Ventura, CASt. Vincents Medical Center· Jacksonville, FL

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