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

Conditions

• Atrial Fibrillation

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

First listed

Apr 14, 2026

Start date

Aug 5, 2026

Status verified

Jun 2026

Primary completion

Nov 30, 2028

Completion

Aug 4, 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

• Narvelle Delabruere
  949-933-1710
  [email protected]

Locations (19)

Find similar trials in Birmingham, AL

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