Left Roof Linear, Mitral Isthmus Linear and Left Anterior Septal Linear Ablation for Non-paroxysmal AF: PROMISED Trial.
Recruiting · NCT06249347 · Interventional (participants receive a specific treatment) · Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
View the official record on ClinicalTrials.gov →Interventions studied
CPVI and LAACPROMISEDRadiofrequency ablation catheterleft atrial appendage occlusion device
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
1 location listed.
- Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University - Wenzhou, Zhejiang, China