NCT06249347 Left Roof Linear, Mitral Isthmus Linear and Left Anterior Septal Linear Ablation for Non-paroxysmal AF: PROMISED Trial.
| NCT ID | NCT06249347 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital of Wenzhou Medical University |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 166 participants |
| Start Date | 2024-01-28 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 166 participants in total. It began in 2024-01-28 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion criteria: 1. Age \> 18 years; 2. Persistent AF (AF duration \> 7 days); 3. CHA2DS2-VASc score ≥2; 4. 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: 1. Previous atrial fibrillation ablation 2. Transthoracic echocardiography suggests that the anteroposterior diameter of the left atrium is greater than 60 mm; 3. persistent AF that lasts \>10 years 4. Scheduled cardiac surgical intervention. 5. Documented left atrial thrombus/ left atrial appendage thrombus or another abnormality that precludes catheter/LAAC introduction 6. Life expectancy less than 1 year
Contact & Investigator
Yue-chun Li, MD
PRINCIPAL INVESTIGATOR
Second Affiliated Hospital of Wenzhou Medical University
Frequently Asked Questions
Who can join the NCT06249347 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06249347 currently recruiting?
Yes, NCT06249347 is actively recruiting participants. Contact the research team at liyuechun1980@sina.com for enrollment information.
Where is the NCT06249347 trial being conducted?
This trial is being conducted at Wenzhou, China.
Who is sponsoring the NCT06249347 clinical trial?
NCT06249347 is sponsored by Second Affiliated Hospital of Wenzhou Medical University. The principal investigator is Yue-chun Li, MD at Second Affiliated Hospital of Wenzhou Medical University. The trial plans to enroll 166 participants.
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