Pulmonary vein isolation alone versus pulmonary vein isolation plus linear ablation for persistent atrial fibrillation

Linear Ablation Added to Pulmonary Vein Isolation Versus Pulmonary Vein Isolation Alone Using Pulsed Field Ablation for Persistent Atrial Fibrillation: a Multi-center Randomized Controlled Trial

This study will test whether adding linear ablation to pulmonary vein isolation using pulsed field ablation helps people with persistent atrial fibrillation stay in normal heart rhythm.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 640 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Boston Scientific Corporation (industry)
• Locations: 1 site (Beijing)
• Trial ID: NCT07106970 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, open-label, randomized controlled trial that assigns adults with persistent AF 1:1 to pulmonary vein isolation (PVI) using pulsed field ablation (PFA) alone or to PVI plus planned linear ablations. The PVI-plus-linear arm includes bilateral PVI and linear lesions on the posterior wall, mitral isthmus and cavo-tricuspid isthmus, with optional ethanol infusion of the vein of Marshall (EIVOM) recommended before PFA at operator discretion. If AF cannot be terminated during the procedure, electrical cardioversion will be used. All participants are followed at discharge, at 1 month, and then every 3 months up to 12 months with rhythm monitoring to document maintenance of sinus rhythm.

Who should consider this trial

Good fit: Adults aged 18–80 with symptomatic, drug‑resistant persistent atrial fibrillation who are undergoing their first ablation and can provide informed consent and attend follow-up visits are eligible.

Not a fit: Patients with prior AF ablation, paroxysmal AF (not persistent), age over 80, or other exclusion criteria and major contraindications are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, adding linear ablation to PVI with PFA could increase the proportion of people with persistent AF who remain in normal rhythm after ablation.

How similar studies have performed: Previous studies of adding linear lesions to PVI have shown mixed results, and pulsed field ablation is a newer technology with limited published outcome data specifically in persistent AF.

Eligibility criteria

Inclusion Criteria:

Study subjects are required to meet all the following inclusion criteria:

1. Subjects with an age range of 18 years or above and 80 years or below.
2. Subjects have symptomatic, drug-resistant, persistent AF, defined as:

   1. Symptomatic: these symptoms include but not limited to palpitations, presyncope, syncope, fatigue, and shortness of breath.
   2. Drug-resistant: effectiveness failure of, intolerance to, or specific contraindication to at least one AAD.
   3. Persistent: continuous AF for \> 90 days, i) with a minimum a physician's note confirming the diagnosis AND,within 180 days of Enrollment Date, either a 24-hour or longer continuous ECG recording confirming continuous AF OR Two ECGs showing continuous AF taken at least 90 days apart.
3. Subjects undergoing a first-time ablation procedure for AF.
4. Subjects who are willing and capable of providing ICF and participating in all testing associated with this study.

Exclusion Criteria:

1. AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible/non-cardiac causes.
2. Left atrial anteroposterior diameter ≥ 6.0 cm by transthoracic echocardiography (TTE) within 3 months prior the procedure.
3. Heart failure with left ventricular ejection fraction (LVEF) \< 30% by TTE within 3 months prior the procedure.
4. LA thrombus detected by Transesophageal Echocardiography (TEE) or cardiac CT within one day before the procedure or Intracardiac Echocardiography (ICE) before atrial septal puncture during the procedure.
5. Current or anticipated pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices, mechanical valve, interatrial baffle, closure device, patch, or patent foramen oval occlude, left atrial appendage closure at the time of ablation.
6. Any of the following events within 90 days of the Consent Date:

   1. Myocardial infarction, unstable angina or coronary intervention or any cardiac surgery
   2. Pericarditis or symptomatic pericardial effusion
   3. Gastrointestinal bleeding
   4. Stroke, transient ischemic attack (TIA), or intracranial bleeding or any non-neurologic thromboembolic event
7. Contraindication to, or unwillingness to use systemic anticoagulation.
8. Subjects cannot be removed from Class I/III AAD for reasons other than atrial arrhythmia.
9. Women of childbearing potential who are pregnant or lactating.
10. Renal insufficiency if an estimated glomerular filtration rate (eGFR) is \< 30 mL/min/1.73 m2, or with any history of renal dialysis or renal transplant.
11. Conditions that in the investigator's medical opinion would interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation.
12. Predicted life expectancy less than 12 months.

Where this trial is running

Beijing

• Beijing Anzhen Hospital, affiliated to Capital Medical University — Beijing, China (RECRUITING)

Study contacts

• Principal investigator: Changsheng Ma, Doctor — Beijing Anzhen Hospital of the Capital University of Medical Sciences
• Study coordinator: Taimin Yue

Conditions: Persistent Atrial Fibrillation