Left Roof Linear, Mitral Isthmus Linear and Left Anterior Septal Linear Ablation for Non-paroxysmal AF: PROMISED Trial.

Launched by SECOND AFFILIATED HOSPITAL OF WENZHOU MEDICAL UNIVERSITY · Jan 31, 2024

Keywords

ClinConnect Summary

The PROMISED Trial is studying a new treatment approach for patients with persistent atrial fibrillation (AF), a condition where the heart beats irregularly. This trial compares a comprehensive procedure that includes isolating the pulmonary veins, performing specific linear ablations, and closing off a part of the heart called the left atrial appendage, to a simpler approach that only involves isolating the pulmonary veins and closing the left atrial appendage. The goal is to see if this new method leads to better long-term results for patients who are not well-suited for long-term blood-thinning medications.

To participate in this trial, you need to be over 18 years old and have had persistent AF for more than 7 days. You should also have a certain risk score indicating you may benefit from this treatment. However, if you've already had AF treatment before, have certain heart conditions, or have a life expectancy of less than a year, you may not be eligible. If you join the trial, you’ll receive care from a team of medical professionals and will be closely monitored throughout the process to help ensure your safety and health.

Gender

ALL

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