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NCT Number: NCT06866704

Pulsed-Field Ablation vs. Radiofrequency Ablation CombIned With Vein of Marshall Ethanol Ablation on Mitral Isthmus Block and Clinical Outcomes in Persistent Atrial Fibrillation

Atrial fibrillation (AF) is one of the most common clinical arrhythmias, and catheter ablation serves as a critical therapeutic approach. For persistent atrial fibrillation, several proposed ablation strategies-including the 2C3L technique, BOX lesion sets, and substrate modification-remain highly controversial regarding long-term success rates. Multiple studies suggest that linear ablation beyond pulmonary vein isolation (PVI) often fails to achieve durable block due to incomplete ablation lines, which significantly contributes to postoperative recurrence of atrial arrhythmias.

In recent years, electrophysiologists have explored various methods to improve mitral isthmus (MI) ablation, such as combined endo-epicardial ablation and radiofrequency ablation (RFA) combined with Marshall vein alcohol ablation. While RFA combined with anhydrous alcohol injection into the Marshall vein enhances MI block rates, it is associated with prolonged procedure time, unpredictable ablation zones, and higher complication risks (e.g., coronary artery spasm, pericarditis).

Pulsed field ablation (PFA), an emerging non-thermal ablation technology, offers potential advantages such as tissue selectivity, shorter procedure time, and fewer complications. Studies report that RFA achieves near 100% immediate block rates; however, there is a lack of sufficient comparative studies on the efficacy and safety between these two ablation approaches. This study aims to compare the clinical outcomes and safety profiles of PFA versus RFA combined with Marshall vein alcohol injection in patients with persistent AF.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Persistent atrial fibrillation;
  • Ejection fraction >30%;
  • NYHA functional class I-III;
  • Left atrial diameter <55 mm on echocardiography;
  • Signed informed consent form;

Exclusion criteria

  • Pregnant or lactating women;
  • Patients with a life expectancy of less than 2 years due to non-cardiovascular factors;
  • Uncontrolled hyperthyroidism, severe liver or kidney dysfunction;
  • History of atrial fibrillation ablation;
  • History of heart transplantation, complex congenital heart disease, or rheumatic heart disease;
  • Contraindications to contrast agents, radiofrequency ablation, antiarrhythmic drugs, or anticoagulants;
  • Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular 8.accident within 12 weeks prior to enrollment;

9.Other conditions deemed unsuitable for participation by investigators; 10.Participation in other clinical trials.

Treatment and study plan

Catheter ablation

Procedure

In the experimental group, patients receive pulsed field ablation (PFA) to achieve pulmonary vein isolation (PVI), circumferential BOX ablation around bilateral pulmonary veins, and mitral isthmus ablation. In the control group, anhydrous alcohol is first injected into the Marshall vein, followed by radiofrequency catheter ablation to complete PVI, BOX lesion sets, and mitral isthmus ablation.

Primary outcomes

  1. Immediate success rate of mitral isthmus ablation block

    Time frame: immediately after the procedure

    Bidirectional MI block was confirmed by the following criteria: (1) proximal-to-distal CS activation pattern when pacing at the left lateral ridge; (2) longer SA interval at the left lateral ridge when pacing at the distal CS compared to pacing at the proximal CS

  2. Mitral isthmus block rate

    Time frame: 20 minutes after the procedure

    Bidirectional MI block was confirmed by the following criteria: (1) proximal-to-distal CS activation pattern when pacing at the left lateral ridge; (2) longer SA interval at the left lateral ridge when pacing at the distal CS compared to pacing at the proximal CS

Secondary outcomes

  1. The incidence of atrial arrhythmias (tachycardia, atrial flutter, atrial fibrillation) over 30 seconds without antiarrhythmic drugs was followed up for 12 months.

    Time frame: 1 year

    The incidence of atrial arrhythmias (tachycardia, atrial flutter, atrial fibrillation) over 30 seconds without antiarrhythmic drugs was followed up for 12 months.

  2. time of operation

    Time frame: immediately after the procedure

    Total operating time,Ablation time,Mitral isthmus ablation time,Radiation time;

  3. complication

    Time frame: 2 weeks after the procedure

    Incidence of pericardial tamponade, acute heart failure, pericardial effusion, pleural effusion; Puncture complications; Incidence of cerebral infarction and TIA; Death;

Study contacts

Contact information is provided by the study sponsor or research team.

Zhiyu Ling, PhD

CONTACT

[email protected]

+86 13512362075

Sponsors and collaborators

Lead sponsor

lingzhiyu

Other

Registry information

Official study title

Pulsed-Field Ablation vs. Radiofrequency Ablation CombIned With Vein of Marshall Ethanol Ablation on Mitral Isthmus Block and Clinical Outcomes in Persistent Atrial Fibrillation: The PRIME-AF Randomized Clinical Trial

Acronym: PRIME-AF

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 10, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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