New ablation technique for persistent atrial fibrillation
Official title: 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.
Run by Second Affiliated Hospital of Wenzhou Medical University · NCT06249347 · Data updated 2026-11-12
This study is testing a new treatment for people with persistent atrial fibrillation to see if a combination of techniques can help them feel better and have fewer heart problems compared to standard care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 166 (estimated) |
| Sponsor | Second Affiliated Hospital of Wenzhou Medical University Academic / other |
| Locations | 1 site (Wenzhou, Zhejiang) |
| Status | Recruiting |
| Started | January 28, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | February 12, 2024 |
| Trial ID | NCT06249347 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 with persistent atrial fibrillation lasting more than 7 days and a CHA2DS2-VASc score of 2 or higher.
✕Probably not a fit
Patients with a history of previous atrial fibrillation ablation or those with significant structural heart abnormalities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates a novel treatment approach for patients with non-paroxysmal atrial fibrillation (AF) that combines circumferential pulmonary vein isolation with additional linear ablation techniques and left atrial appendage occlusion. The goal is to determine if this comprehensive strategy improves long-term success rates compared to standard treatments. Participants will be randomly assigned to either the new treatment group or a control group receiving standard care. The study aims to assess both the efficacy and safety of this combined approach.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance the long-term management of persistent atrial fibrillation, reducing recurrence rates and improving patient outcomes.
How similar studies have gone: While the approach is innovative, similar studies have shown promise in improving outcomes for atrial fibrillation patients, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China Recruiting
Study contacts
- Principal investigator: Yue-chun Li, MD — Second Affiliated Hospital of Wenzhou Medical University
- Study coordinator: Yue-chun Li, MD
- Email: liyuechun1980@sina.com
- Phone: +86-0577-8567-6610
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Using electrical cardioversion to improve heart rhythm after surgery
This study tests if using electrical shocks to reset the heart rhythm can help patients with persistent atrial fibrillation feel better after heart surgery.
-
Ablation of focal activation in atrial fibrillation
This study is testing a new method to find specific electrical signals that may be causing ongoing atrial fibrillation in patients, to see if targeting these signals can improve their treatment.
-
Hybrid ablation for treating persistent atrial fibrillation
This study is testing a new hybrid treatment for people with persistent atrial fibrillation to see if it works better than the standard catheter procedure in helping them stay free from heart rhythm problems.
-
AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals
This study tests AI-powered tools on real-world stroke patients to see if they can improve pre-hospital triage, diagnosis, and outcome prediction while data stay securely within each hospital.
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Left-atrial Fibrosis in Persistent Atrial Fibrillation and Its Comorbidities
This study tests how comorbid conditions like sleep apnea and primary aldosteronism relate to left-atrial fibrosis and AF recurrence in patients undergoing ablation.
-
Dual Energy ablation with SmartTouch SF catheter in persistent atrial fibrillation
This study tests a pulsed field and radiofrequency ablation system to treat persistent atrial fibrillation in adults who have not responded well to prior medications.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.