Left Roof Linear, Mitral Isthmus Linear and Left Anterior Septal Linear Ablation for Non-paroxysmal AF: PROMISED Trial.
Recruiting now · Not applicable
Conditions studied: Atrial Fibrillation, Atrial Fibrillation, Persistent
In brief
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.
Key facts
- Study ID
- NCT06249347
- Run by
- Second Affiliated Hospital of Wenzhou Medical University
- People needed
- 166
- Starts
- 2024-01-28
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2024-02-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age > 18 years;
- Persistent AF (AF duration > 7 days);
- CHA2DS2-VASc score ≥2;
- 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;
You may not qualify if…
- Previous atrial fibrillation ablation
- Transthoracic echocardiography suggests that the anteroposterior diameter of the left atrium is greater than 60 mm;
- persistent AF that lasts >10 years
- Scheduled cardiac surgical intervention.
- Documented left atrial thrombus/ left atrial appendage thrombus or another abnormality that precludes catheter/LAAC introduction
- Life expectancy less than 1 year
Where it is running
- Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (enrolling)
Full record on ClinicalTrials.gov
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