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NCT07633509

The COMBINE-AF Trial

Sponsor: Yunlong Wang

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

430

Start Date

2026-06-15

Completion Date

2029-12-31

Last Updated

2026-06-08

Healthy Volunteers

Conditions

Atrial Fibrillation (AF)Atrial Fibrillation Catheter Ablation

Interventions

DEVICE

Pulsed Field Ablation Catheter

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.

DRUG

Ethanol

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

DEVICE

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.

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, deep vein thrombosis; or arterial thromboembolic disease: acute coronary syndrome, lower extremity arterial embolism, stroke). * Left atrial myxoma. * Severe respiratory disease. * Active infectious disease. * Poorly controlled or active systemic immune disease (equivalent to glucocorticoid use \>2 tablets/day). * Unresolved malignant hematologic disease, or currently receiving chemotherapy, radiotherapy, or immunotherapy. * Unresolved malignant solid tumor, or currently receiving chemotherapy, radiotherapy, or immunotherapy. * Untreated hypothyroidism or hyperthyroidism. * Severe hepatic insufficiency (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] \>3 times the upper limit of normal). * End-stage renal failure requiring dialysis. * Other serious arrhythmias, such as hemodynamically unstable ventricular tachycardia. * Pregnancy or breast-feeding. * Psychiatric disorder. * Body mass index (BMI) \<18.5 or \>35.0 kg/m². * Life expectancy \<2 years.

Locations (3)

Fuwai Hospital

Beijing, Beijing Municipality, China

Beijing Anzhen Hospital, Capital Medical University