The COMBINE-AF Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorYunlong Wang
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Linear ablation of mitral isthmus and tricuspid isthmus
Procedure/SurgeryUse 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
DrugInfusion of absolute ethanol into the vein of Marshall (VOM) under balloon occlusion to facilitate mitral isthmus linear ablation.
Radiofrequency Ablation Catheter
Procedure/SurgeryUse 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.
Treatment groups
430 Participants
are divided into 2 treatment groupsGroup A: Pulmonary Vein Isolation + Posterior Wall Isolation (PFA Only)Active comparator 1 intervention
Group B: PVI + Posterior Wall + Modified Linear Ablation (PFA + RF)Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Freedom from Atrial Arrhythmia Recurrence at 12 Months
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.
Time frame
Between 3 months and 12 months following the ablation procedure, excluding the initial 3-month blanking periodSecondary outcomes
1
Atrial Fibrillation Burden at 12 Months
AF burden is defined as the percentage of time spent in atrial fibrillation (AF), atrial flutter, or atrial tachycardia during the 12-month follow-up period, excluding the 3-month blanking period. Burden is assessed using 24-hour Holter monitoring at 6 and 9 months and 7-day Holter monitoring at 12 months post-ablation. The percentage of AF days (defined as days on which Holter recording shows any AF/AFL/AT episode) among total monitored days will also be reported as a secondary measure.
Time frame
From month 3 to month 12 after the ablation procedure2
Incidence of Serious Procedure-Related Complications
Proportion of participants experiencing at least one serious adverse event related to the ablation procedure or device. Serious complications include cardiac tamponade requiring intervention, atrio-esophageal fistula, periprocedural stroke or transient ischemic attack, pulmonary vein stenosis, hemolysis requiring renal replacement therapy, coronary events (including spasm requiring unplanned angiography), and death.
Time frame
From the start of the ablation procedure to 30 days post-procedure3
Cardiovascular Hospitalization During Follow-up
Any hospitalization for cardiovascular causes (including heart failure, arrhythmia recurrence, stroke, or other cardiac events) during the 12-month follow-up period after ablation.
Time frame
From the date of ablation to 12 months post-ablation4
Total Procedure Time
Total procedure time measured in minutes from first femoral venous access to final sheath removal.
Time frame
On the day of the ablation procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yunlong Wang
Lead sponsor
Beijing Anzhen Hospital
Sponsor institution
Beijing Huahsia Foundation
Collaborator
Boston Scientific Corporation
Collaborator
Source ClinicalTrials.gov
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