Actively Recruiting
Left Roof Linear, Mitral Isthmus Linear and Left Anterior Septal Linear Ablation for Non-paroxysmal AF: PROMISED Trial.
Led by Second Affiliated Hospital of Wenzhou Medical University · Updated on 2024-02-12
166
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Left Roof Linear, Mitral Isthmus Linear and Left Anterior Septal Linear Ablation for Non-paroxysmal AF: PROMISED Trial.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- Persistent atrial fibrillation lasting more than 7 days
- CHA2DS2-VASc score of 2 or higher
- Unsuitable for long-term standardized anticoagulation therapy, or
- History of stroke or embolism despite long-term standardized anticoagulation therapy, or
- HAS-BLED score 3 or higher, or
- Unwillingness to undergo long-term anticoagulation therapy
You will not qualify if you...
- Previous atrial fibrillation ablation
- Left atrium anteroposterior diameter greater than 60 mm on transthoracic echocardiography
- Persistent atrial fibrillation lasting more than 10 years
- Scheduled cardiac surgical intervention
- Documented left atrial or left atrial appendage thrombus or other abnormalities preventing catheter or device introduction
- Life expectancy less than 1 year
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
Y
Yue-chun Li, MD
CONTACT
Y
Yuan-nan Lin, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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