Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment166 (estimated)
SponsorSecond Affiliated Hospital of Wenzhou Medical University
Academic / other
Locations1 site (Wenzhou, Zhejiang)
StatusRecruiting
StartedJanuary 28, 2024
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedFebruary 12, 2024
Trial IDNCT06249347 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

  • Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
    Wenzhou, Zhejiang, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.