A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior Vena Cava Isolation

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Biosense Webster, Inc.
Study ID
NCT07527299
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • VARIPULSE Catheter System — DEVICE
    Pulsed field ablation by VARIPULSE Catheter System (VARIPULSE bi-directional catheter and TRUPULSE generator) will be used.
  • LAAO Device — DEVICE
    LAAO procedures will be performed using commercially available LAAO devices in accordance with the device's instruction for use (IFU).

Study Details

The purpose of this study is to assess how safe VARIPULSE catheter system is for treatment of a heart rhythm disease called persistent atrial fibrillation (PsAF) in participants who are having a catheter ablation procedure (treat heart rhythm disease). This includes isolation of pulmonary vein and superior vena cava (heart veins; PVI and SVCI), with or without another technique called posterior wall isolation (PWI). Also, to assess how safe it is for participants who are having a catheter ablation procedure and at the same time receiving another procedure called left atrial appendage occlusion (LAAO; to reduce stroke risk). Additionally, to assess how well VARIPULSE catheter system works over a long period of time for treatment of PsAF in participants undergoing catheter ablation.

Key Dates

Start date
May 29, 2026
Status verified
May 2026
Primary completion
Nov 30, 2028
Completion
May 23, 2031

Study Design

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

Arms

  • Experimental: VARIPULSE Catheter System: PVI and SVCI
    Participants with persistent atrial fibrillation (PsAF) undergoing catheter ablation for the first-time with the VARIPULSE Catheter System will undergo the ablation procedure for PVI and SVCI. Additionally, a subset of participants will undergo a concomitant left atrial appendage occlusion (LAAO) procedure. All participants will be followed for up to 36 months post procedure.
  • Experimental: VARIPULSE Catheter System: PVI and SVCI + PWI
    Participants with PsAF undergoing catheter ablation for the first-time with VARIPULSE catheter system will undergo the ablation procedure for PVI and SVCI along with posterior wall isolation (PWI). Additionally, a subset of participants will undergo a concomitant LAAO procedure. All participants will be followed for up to 36 months post procedure.

Primary Outcome Measure

Number of Participants with Early Onset Primary Adverse Events (PAEs) [ Time Frame: Up to approximately 7 days post-procedure ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Tucson Medical CenterTucsonArizona85712-
Arrhythmia Research GroupJonesboroArkansas72401-
Albert Einstein College Of Medicine - Montefiore Medical CenterThe BronxNew York10467-

Find similar trials in Tucson, AZ

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
Tucson Medical Center· Tucson, AZArrhythmia Research Group· Jonesboro, ARAlbert Einstein College Of Medicine - Montefiore Medical Center· The Bronx, NY

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