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.
Status: Recruiting
Location: See location...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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;
Locations
Other Locations
China
Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Contact Information
Primary
Yue-chun Li, MD
liyuechun1980@sina.com
+86-0577-8567-6610
Backup
Yuan-nan Lin, MD
597049712@qq.com
+86-0577-8567-6610
Time Frame
Start Date:2024-01-28
Estimated Completion Date:2026-12-31
Participants
Target number of participants:166
Treatments
Experimental: PROMISED
Guided by a circular mapping catheter, all patients initially underwent wide-area circumferential pulmonary vein isolation (CPVI) using radiofrequency ablation catheter. If sinus rhythm was restored after performing the CPVI ablation, the ablation procedure would be stopped. If AF persisted, patients underwent linear ablation (roof linear ablation+anterior septal linear ablation+mitral isthmus linear ablation) using radiofrequency ablation catheter. Then, guided by left atrial appendage (LAA) angiography, the operators selected an appropriately sized left atrial appendage occlusion device according to the LAA size and morphology.~Interventions:~Procedure: CPVI+ roof linear ablation + anterior septal linear ablation + mitral isthmus linear ablation + Left atrial appendage closure (LAAC)
Active_comparator: CPVI and LAAC
Guided by a circular mapping catheter, all patients initially underwent wide-area CPVI using radiofrequency ablation catheter. Then, guided by LAA angiography, the operators selected an appropriately sized left atrial appendage occlusion device according to the LAA size and morphology.~Interventions:~Procedure: CPVI and LAAC