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RECRUITING
NCT07106970
NA

PVI Alone vs PVI and Linear Ablation for Persistent Atrial Fibrillation (PROMPT AF II)

Sponsor: Boston Scientific Corporation

View on ClinicalTrials.gov

Summary

This study is a prospective, multicenter, open-label, randomized controlled trial to investigate whether a linear ablation in addition to pulmonary vein isolation (PVI) outperforms PVI alone using pulsed field ablation (PFA) in maintaining sinus rhythm for persistent atrial fibrillation (PerAF)

Official title: Linear Ablation Added to Pulmonary Vein Isolation Versus Pulmonary Vein Isolation Alone Using Pulsed Field Ablation for Persistent Atrial Fibrillation: a Multi-center Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

640

Start Date

2025-08-28

Completion Date

2028-04-30

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

PROCEDURE

Linear ablation

Linear ablations in the posterior wall (PW), mitral isthmus (MI) and cavo-tricuspid isthmus (CTI) using the study device.EIVOM could be performed additionally before or after PFA at the operator's discretion.

PROCEDURE

PVI alone

Undergo PVI with the study device

Locations (1)

Beijing Anzhen Hospital, affiliated to Capital Medical University

Beijing, China