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Left Roof Linear, Mitral Isthmus Linear and Left Anterior Septal Linear Ablation for Non-paroxysmal AF: PROMISED Trial.

RECRUITINGN/ASponsored by Second Affiliated Hospital of Wenzhou Medical University
Actively Recruiting
PhaseN/A
SponsorSecond Affiliated Hospital of Wenzhou Medical University
Started2024-01-28
Est. completion2026-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

The purpose of this prospective randomized study is to assess whether a new treatment strategy consisting of circumferential Pulmonary vein isolation (PVI), left ROof linear (RL), Mitral Isthmus linear (MIL), and left anterior SEptal linear (ASL) ablation and left atrial appendage (LAA) Device occlusion (PROMISED procedure) is superior to the PVI combined LAA closure in enhancing the long-term success rate of catheter ablation in non-paroxysmal atrial fibrillation (AF) patients.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion criteria:

1. Age \> 18 years;
2. Persistent AF (AF duration \> 7 days);
3. CHA2DS2-VASc score ≥2;
4. Presence of at least one of the following conditions:

   * Unsuitable for long-term standardized anticoagulation therapy;
   * Stroke or embolism still occurred based on long-term standardized anticoagulation therapy;
   * HAS-BLED score ≥3;
   * Unwillingness for long-term anticoagulation therapy;

Exclusion Criteria:

1. Previous atrial fibrillation ablation
2. Transthoracic echocardiography suggests that the anteroposterior diameter of the left atrium is greater than 60 mm;
3. persistent AF that lasts \>10 years
4. Scheduled cardiac surgical intervention.
5. Documented left atrial thrombus/ left atrial appendage thrombus or another abnormality that precludes catheter/LAAC introduction
6. Life expectancy less than 1 year

Conditions3

Atrial FibrillationAtrial Fibrillation, PersistentHeart Disease

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