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

NCT07106970 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 640

Last updated 2026-05-01

No results posted yet for this study

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)

Conditions

  • Persistent Atrial Fibrillation

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

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Changsheng Ma, Doctor · Beijing Anzhen Hospital of the Capital University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-28
Primary Completion
2027-09-30
Completion
2028-04-30

Countries

  • China

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 NCT07106970 on ClinicalTrials.gov