The COMBINE-AF Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

Linear ablation of mitral isthmus and tricuspid isthmus: Use of a pentaspline pulsed field ablation (PFA) catheter to perform circumferential pulmonary vein isolation (PVI) and left atrial posterior wall box isolation. The endpoint is confirmed bidirectional block of all targeted veins and the posterior wall.

Ethanol: Infusion of absolute ethanol into the vein of Marshall (VOM) under balloon occlusion to facilitate mitral isthmus linear ablation.

Radiofrequency Ablation Catheter: Use of a contact-force sensing radiofrequency (RF) ablation catheter to create modified linear lesions: mitral isthmus line (combined with ethanol infusion) and cavotricuspid isthmus line. The goal is bidirectional block across all linear lesions.

Study summary

The goal of this clinical trial is to test if a more complete ablation procedure works better than the standard procedure for people with long-lasting persistent atrial fibrillation (AF). AF is a heart rhythm problem that can cause a fast or uneven heartbeat.

This study will include 430 people with long-lasting AF that has lasted 1 to 3 years. Participants will be put into one of two groups by chance:

First group (control): They will receive pulsed-field ablation (PFA), a type of energy that can stop the faulty heart signals. They will have isolation of the pulmonary veins and the posterior wall of the left atrium.

Second group (study): They will receive the same PFA procedure plus extra ablation lines (modified linear ablation) using radiofrequency energy. This includes ablation of the mitral isthmus (with ethanol infusion into a small vein called the vein of Marshall) and the cavotricuspid isthmus.

Participants will be followed for 12 months after the procedure with clinic visits, electrocardiograms (ECGs), and heart rhythm monitors. The main outcome is whether participants stay in normal heart rhythm (sinus rhythm) without any AF episodes lasting more than 30 seconds at 12 months. Researchers will also look at procedure time, complication rates, quality of life, and other rhythm outcomes.

This study will help show if the more complete ablation procedure leads to better long-term results for people with long-lasting AF.

Eligibility

Primary outcome measure(s)

• Freedom from Atrial Arrhythmia Recurrence at 12 Months — Between 3 months and 12 months following the ablation procedure, excluding the initial 3-month blanking period
  The primary outcome is the proportion of participants remaining in normal sinus rhythm at 12 months after the ablation procedure, after excluding a 3-month blanking period immediately following the procedure. Treatment success is defined as freedom from any documented episode of atrial fibrillation, atrial flutter, or atrial tachycardia lasting more than 30 seconds, as recorded by electrocardiogram (ECG) or Holter monitoring between 3 months and 12 months post-ablation.

Trial sites (3)

More Yunlong Wang trials in China

Other trials for the same condition