New ablation technique for persistent atrial fibrillation

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.

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

• Phase: NA
• Study type: Interventional
• Enrollment: 166 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Second Affiliated Hospital of Wenzhou Medical University (other)
• Locations: 1 site (Wenzhou, Zhejiang)
• Trial ID: NCT06249347 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: While the approach is innovative, similar studies have shown promise in improving outcomes for atrial fibrillation patients, suggesting potential for success.

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

Where this trial is running

Wenzhou, Zhejiang

• 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

Conditions: Atrial Fibrillation, Atrial Fibrillation, Persistent, non-paroxysmal atrial fibrillation, left atrial anterior wall ablation, roof linear ablation, mitral isthmus linear ablation