NCT07633509Not yet recruiting
The COMBINE-AF Trial
A Multicenter, Prospective, Randomized Controlled Trial of Combined Pulsed-Field and Radiofrequency-Modified Linear Ablation Versus Pulsed-Field Ablation Alone for Long-Standing Persistent Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 27 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 430 (estimated)
- First submitted
- 2 Jun 2026
- Start date
- 27 Jul 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Yunlong Wang
- Diseases
- Atrial fibrillation
- NCT number
- NCT07633509
What you commit to
- Study type: Interventional
- Planned participants: 430
- From 27 Jul 2026 to the primary completion date, 31 Dec 2028
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior catheter ablation for atrial fibrillation.
- Unresolved malignant hematologic disease, or currently receiving chemotherapy, radiotherapy, or immunotherapy.
- Unresolved malignant solid tumor, or currently receiving chemotherapy, radiotherapy, or immunotherapy.
Other illness
- Coexisting severe organic heart disease (e.g., severe valvular heart disease, hypertrophic cardiomyopathy, dilated cardiomyopathy, etc.).
- Known allergy or contraindication to low-molecular-weight heparin, warfarin, or direct oral anticoagulants.
- Allergy to alcohol or contrast media.
- Unstable angina pectoris.
- Cardiac surgery within the past 6 months.
- Planned heart transplantation.
- History of thromboembolic disease within the past 6 months (including venous thromboembolism: pulmonary embolism, deep vein thrombosis; or arterial thromboembolic disease: acute coronary syndrome, lower extremity arterial embolism, stroke).
- Severe respiratory disease.
- Active infectious disease.
- Poorly controlled or active systemic immune disease (equivalent to glucocorticoid use \>2 tablets/day).
- End-stage renal failure requiring dialysis.
- Other serious arrhythmias, such as hemodynamically unstable ventricular tachycardia.
- Psychiatric disorder.
Lab values
- Left ventricular ejection fraction (LVEF) \<40%.
- Severe hepatic insufficiency (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] \>3 times the upper limit of normal).
Age
- Life expectancy \<2 years.
Other
- 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.
- Left atrial diameter (LAD) \>55 mm.
- Undergoing a "one-stop" procedure combining atrial fibrillation ablation with left atrial appendage closure.
- Pulmonary artery systolic pressure \>50 mmHg.
- Percutaneous coronary intervention (PCI) within the past 3 months.
- Left atrial myxoma.
- Untreated hypothyroidism or hyperthyroidism.
- Pregnancy or breast-feeding.
- Body mass index (BMI) \<18.5 or \>35.0 kg/m².
Who the study is looking for
- Symptomatic patients with long-standing persistent atrial fibrillation.
- Duration of atrial fibrillation between 1 and 3 years.
- Age 18 to 75 years.
- Documentation of atrial fibrillation within 3 years prior to enrollment.
- Willing and able to comply with the study protocol and provide written informed consent.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Fuwai Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Jiangsu Province Hospital（The First Affiliated Hospital With Nanjing Medical University, Jiangsu Women And Children Health Hospital) Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.