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Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation

NCT06096337 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 484

Last updated 2026-03-31

No results posted yet for this study

Summary

The purpose of this study is to establish the safety and effectiveness of pulsed field ablation as a first-line ablation treatment for subjects with persistent atrial fibrillation as compared to subjects who received an initial treatment with anti-arrhythmic drugs.

Conditions

  • Persistent Atrial Fibrillation

Interventions

DEVICE

FARAPULSE™ Pulsed Field Ablation (PFA) System

Subjects will undergo a pulsed field ablation procedure using the FARAPULSE™ Pulsed Field Ablation (PFA) System for the isolation of pulmonary veins and posterior wall.

DRUG

Anti-Arrhythmic Drug (AAD): Flecainide, Sotalol, Propafenone, Dofetilide, and Dronedarone

Anti-Arrhythmic Drugs (AADs) including, Flecainide, Sotalol, Propafenone, Dofetilide, and Dronedarone will be prescribed and monitored in accordance with local clinical practice and already established guideline-directed therapy for patients with persistent atrial fibrillation (AF).

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Oussama Wazni, M.D. · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-28
Primary Completion
2026-02-04
Completion
2028-02-04
FDA Device
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Croatia
  • France
  • Germany
  • Hong Kong
  • Italy
  • Singapore
  • Spain
  • Taiwan

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 NCT06096337 on ClinicalTrials.gov