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

StatusRecruiting
PhaseNot applicable
Started2025-08-28
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Sep 30, 2027 → Dec 30, 2027
See other at-risk trials from Boston Scientific Corporation

Amendment history

2026-08-14
Study Status v11
Primary completion pushed: 2027-09-30 → 2027-12-30
Completion pushed: 2028-04-30 → 2028-08-30
2026-07-30
8 amendments v3-v10
8 re-verifications since 2025-11-13, no change to tracked fields
2025-09-01
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-08-30→confirmed 2025-08-28
Study sites0→1
2025-08-06
Study Status, Outcome Measures, Eligibility v1
Eligibility criteria+119 characters
[...] Subjects undergoing a first-time ablation procedure for AF. Subjects who have been on anticoagulation therapy for at least 3 weeks prior to the ablation procedure Subjects who are willing and capable of providing ICF and pa [...] on (LVEF) < 30% by TTE within 3 months prior the procedure. LA thrombus detected by Transesophageal Echocardiography (TEE) or cardiac CT within one day before the procedure or Intracardiac Echocardiography (ICE) before atrial septal puncture during the procedure. Current or anticipated pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy dev [...] [...]
Secondary endpoints2 entries, revised
Secondary Effectiveness Endpoint with Chronic Success. Secondary Safety Endpoint with Non-SAE.
Primary endpoints2 entries, revised
Primary Effectiveness Endpoint with Treatment Success. Primary Safety Endpoint with Safety events related to AF catheter ablation.
2025-08-05
Original filing
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)
Trial Details
NCT Number NCT07106970
Lead Sponsor Boston Scientific Corporation
Conditions Persistent Atrial Fibrillation
Enrollment 640 participants
Start Date 2025-08-28
Primary Completion 2027-12-30 (estimated)
Study Completion 2028-08-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-29