The COMBINE-AF Trial (NCT07633509) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The COMBINE-AF Trial
China430 participantsStarted 2026-06-15
Plain-language 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 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 back 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Symptomatic patients with long-standing persistent atrial fibrillation.
* Duration of atrial fibrillation between 1 and 3 years.
* Age 18 to 75 years.
* Left atrial diameter between 43 mm and 55 mm.
* Documentation of atrial fibrillation within 3 years prior to enrollment.
* Willing and able to comply with the study protocol and provide written informed consent.
Exclusion Criteria:
* Paroxysmal atrial fibrillation, or evidence of sinus rhythm on electrocardiogram within the past year.
* Persistent atrial fibrillation lasting less than 1 year or more than 3 years.
* Left atrial thrombus.
* Prior catheter ablation for atrial fibrillation.
* Coexisting severe organic heart disease (e.g., severe valvular heart disease, hypertrophic cardiomyopathy, dilated cardiomyopathy, etc.).
* Left atrial diameter (LAD) \>55 mm.
* Left ventricular ejection fraction (LVEF) \<40%.
* Known allergy or contraindication to low-molecular-weight heparin, warfarin, or direct oral anticoagulants.
* Undergoing a "one-stop" procedure combining atrial fibrillation ablation with left atrial appendage closure.
* Allergy to alcohol or contrast media.
* Pulmonary artery systolic pressure \>50 mmHg.
* Unstable angina pectoris.
* Percutaneous coronary intervention (PCI) within the past 3 months.
* Cardiac surgery within the past 6 months.
* Planned heart transplantation.
* History of thromboembolic disease within the past 6 months (including venous thromboembolism: pulmonary embolism, de…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on catheter ablation for atrial fibrillation — is catheter ablation something you think is appropriate for my specific situation, or should I be trying medication-based options first before considering a surgical approach like this?
2The trial is listed as 'not yet recruiting' — do you have any sense of when it might open, and is it worth waiting to see if I might be eligible, or does my condition need to be addressed sooner than that timeline allows?
3Since this trial doesn't have a traditional phase number, what does that mean for what's already known about the safety and effectiveness of the approach being studied, and how should I weigh that uncertainty?
4The trial's main goal is measuring freedom from atrial arrhythmia recurrence at 12 months — if I were to participate, what would my follow-up schedule look like, and how disruptive might that be to my daily life over that year?
5Are there standard-of-care catheter ablation options already available outside of this trial that I could access now, and how would participating in this study differ from just getting the procedure done through normal care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Freedom from Atrial Arrhythmia Recurrence at 12 Months
Timeframe: Between 3 months and 12 months following the ablation procedure, excluding the initial 3-month blanking period