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

First listed
Apr 13, 2026
Start date
Apr 2, 2026
Status verified
Sep 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. Eligible participants may enter an magnetic resonance imaging (MRI) subset and undergo MRI assessments at baseline and post-ablation 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. Eligible participants may enter an MRI subset and undergo MRI assessments at baseline and post-ablation procedure.

Primary Outcome Measure

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

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Arrhythmia Research GroupJonesboroArkansas72401-
OC Medical CenterFountain ValleyCalifornia92708-
Community Memorial HospitalVenturaCalifornia93003-
NCH HealthcareNaplesFlorida34102-
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

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By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
Arrhythmia Research Group· Jonesboro, AROC Medical Center· Fountain Valley, CACommunity Memorial Hospital· Ventura, CANCH Healthcare· Naples, FLLenox Hill Hospital· New York, NYMontefiore Medical Center· The Bronx, NY

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