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Posterior Wall Substrate Modification Using Irreversible Electroporation for Paroxysmal Atrial Fibrillation

NCT06364215 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2026-05-15

No results posted yet for this study

Summary

The purpose of this study is to compare the efficacy and safety between pulmonary vein isolation (PVI) alone versus PVI with left atrial (LA) posterior wall isolation (PWI) using pulsed-field ablation (PFA) in the treatment of patients with paroxysmal atrial fibrillation (PAF).

Conditions

  • Atrial Fibrillation Paroxysmal

Interventions

DEVICE

Farapulse PFA, Pulmonary Vein Isolation alone

Ablation of the pulmonary veins for the treatment of Paroxysmal Atrial Fibrillation using pulsed field ablation.

DEVICE

Farapulse PFA, Pulmonary Vein Isolation and Left atrial Posterior Wall Isolation

Ablation of the pulmonary veins and the left atrium posterior wall for the treatment of Paroxysmal Atrial Fibrillation using pulsed field ablation.

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Databean

    collaborator INDUSTRY

  • Jorge Romero

    lead OTHER

Principal Investigators

  • Jorge E Romero, MD · Massachusetts General Hospital

  • William H Sauer, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-08
Primary Completion
2025-11-16
Completion
2025-11-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06364215 on ClinicalTrials.gov