The COMBINE-AF Trial

Sponsor
Yunlong Wang
Study ID
NCT07633509
Status
Not Yet Recruiting

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Conditions

  • Atrial Fibrillation (AF)
  • Atrial Fibrillation Catheter Ablation

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Pulsed Field Ablation Catheter — DEVICE
    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 — DRUG
    Infusion of absolute ethanol into the vein of Marshall (VOM) under balloon occlusion to facilitate mitral isthmus linear ablation.
  • Radiofrequency Ablation Catheter — DEVICE
    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 Details

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.

Key Dates

First listed
Jun 8, 2026
Start date
Jun 15, 2026
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
430 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Pulmonary Vein Isolation + Posterior Wall Isolation (PFA Only)
    Participants in this arm receive pulsed-field ablation (PFA) to isolate all four pulmonary veins and to create a box lesion isolating the left atrial posterior wall. No additional linear ablation lines are performed. The procedure endpoint is confirmed bidirectional block of all targeted veins and the posterior wall. CTI ablation will be performed only if typical atrial flutter is documented.
  • Experimental: PVI + Posterior Wall + Modified Linear Ablation (PFA + RF)
    Participants in this arm receive the same PFA-based pulmonary vein isolation and posterior wall box isolation as the control arm. In addition, they undergo modified linear ablation using radiofrequency (RF) energy. This includes: Mitral isthmus line supplemented by ethanol infusion into the vein of Marshall. Cavotricuspid isthmus line. The goal is to achieve bidirectional block across all ablation lines.

Primary Outcome Measure

Freedom from Atrial Arrhythmia Recurrence at 12 Months [ Time Frame: Between 3 months and 12 months following the ablation procedure, excluding the initial 3-month blanking period ]

Central Contacts

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