Tests a new catheter ablation approach for persistent atrial fibrillation
Tests a heart procedure with extra ablation lines in adults with persistent atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Left Roof Linear, Mitral Isthmus Linear and Left Anterior Septal Linear Ablation for Non-paroxysmal AF: PROMISED Trial.
Key facts
- Where
- Wenzhou, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with long-lasting (persistent) atrial fibrillation who cannot or do not want to take long-term blood thinners. It compares two heart ablation procedures, both with a left atrial appendage closure device.
- Age
- Older than 18 years
- Sex
- All sexes can join
- Disease stage
- Persistent atrial fibrillation lasting more than 7 days, with a CHA2DS2-VASc score of 2 or more
- Earlier treatment
- No earlier atrial fibrillation ablation. At least one of these is needed: unsuitable for long-term blood thinners, a stroke or embolism despite blood thinners, a HAS-BLED score of 3 or more, or unwillingness to take long-term blood thinners.
Main reasons for not taking part
- Previous atrial fibrillation ablation
- Left atrium wider than 60 mm front to back on heart ultrasound
- Persistent atrial fibrillation lasting more than 10 years
- Planned heart surgery
- Blood clot in the left atrium or its appendage, or another problem that blocks the catheter or device
Read by machine on 9 November 2026.
Where in China
- Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical UniversityWenzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Second Affiliated Hospital of Wenzhou Medical University
- Trial code
- NCT06249347
- Record updated
- 12 February 2024
- Original description
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.Read full original descriptionShow less
Pulmonary Vein Isolation and Left Roof Linear, Mitral Isthmus Linear, and Left Anterior Septal Linear Ablation, and Left Atrial Appendage Device Occlusion in Patients With Non-paroxysmal Atrial Fibrillation: PROMISED Trial.
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.
Inclusion: 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.
Exclusion: Previous atrial fibrillation ablation; Scheduled cardiac surgical intervention; persistent AF that lasts >10 years; Transthoracic echocardiography suggests that the anteroposterior diameter of the left atrium is greater than 60 mm; Documented left atrial thrombus/ left atrial appendage thrombus or another abnormality that precludes catheter/LAAC introduction; Life expectancy less than 1 year.