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 Jonesboro, Arkansas.

Sponsor
Biosense Webster, Inc.
Study ID
NCT07523750
Status
Recruiting
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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

Start date
Apr 2, 2026
Status verified
Jun 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
466 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 (11)

FacilityCityStateZIPSite coordinators
Arrhythmia Research GroupJonesboroArkansas72401-
Memorial Health University Medical CenterSavannahGeorgia31404-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Rutgers Robert Wood Johnson Medical SchoolNew BrunswickNew Jersey08901-
Lenox Hill HospitalNew YorkNew York10075-
Montefiore Medical CenterThe BronxNew York10467-
WakeMed HospitalRaleighNorth Carolina27610-
Texas Cardiac Arrhythmia Research FoundationAustinTexas78705-
Baylor Research InstitutePlanoTexas75093-
Intermountain Medical CenterMurrayUtah84107-

Find similar trials in Jonesboro, AR

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
Arrhythmia Research Group· Jonesboro, ARMemorial Health University Medical Center· Savannah, GABeth Israel Deaconess Medical Center· Boston, MAMassachusetts General Hospital· Boston, MARutgers Robert Wood Johnson Medical School· New Brunswick, NJLenox Hill Hospital· New York, NY

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