A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Biosense Webster, Inc.
Study ID
NCT07227532
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator — DEVICE
    Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator will be used.

Study Details

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 fibrillation (PAF).

Key Dates

Start date
Oct 21, 2025
Status verified
Jun 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
276 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator
    Participants undergoing electrophysiology mapping and pulsed field ablation (PFA) for management of treatment of symptomatic paroxysmal atrial fibrillation (AF) will undergo pulmonary vein (PV) ablation with the VARIPULSE Catheter with a TRUPULSE Generator.

Primary Outcome Measure

Occurences of Early Onset Primary Adverse Events (PAEs) Within 7 days of the Index Ablation Procedure [ Time Frame: Within 7 days post index procedure ]

Central Contacts

Locations (19)

FacilityCityStateZIPSite coordinators
Phoenix Cardiovascular Research GroupPhoenixArizona85018-
Tucson Medical Center Pima Heart and VascularTucsonArizona85704-
OC MemorialFountain ValleyCalifornia92708-
San Diego Cardiac CenterSan DiegoCalifornia92123-
Stanford Hospital and ClinicsStanfordCalifornia94305-
Community Memorial HospitalVenturaCalifornia93003-
Aurora Denver Cardiology AssociatesAuroraColorado80012-
Colorado Heart and Vascular PCGoldenColorado80401-
Orlando Health Heart and Vascular InstituteOrlandoFlorida32806-
Deaconess Gateway HospitalNewburghIndiana47630-
The Kansas City Heart Rhythm InstituteOverland ParkKansas66211-
Trinity HealthYpsilantiMichigan48197-
Albert Einstein College Of Medicine - Montefiore Medical CenterThe BronxNew York10467-
Springfield Medical CenterSpringfieldOhio45504-
Texas Cardiac Arrhythmia Research FoundationAustinTexas78705-
Baylor Scott and White Research InstituteFort WorthTexas76104-
Baylor Scott & White Research Institute at The Heart Hospital Baylor PlanoPlanoTexas75093-
Winchester Medical CenterWinchesterVirginia22601-
Mercy HospitalJanesvilleWisconsin53548-

Find similar trials in Phoenix, AZ

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
Phoenix Cardiovascular Research Group· Phoenix, AZTucson Medical Center Pima Heart and Vascular· Tucson, AZOC Memorial· Fountain Valley, CASan Diego Cardiac Center· San Diego, CAStanford Hospital and Clinics· Stanford, CACommunity Memorial Hospital· Ventura, CA

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