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

NCT06866704 | Not Yet Recruiting

• 1 other identifier: PRIME-AF
• Study Type: interventional
• Target: 154
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Atrial Fibrillation (AF)

Keywords

persistent atrial fibrillation; pulsed field ablation; EI-VOM

Outcome Measures

Primary Outcomes (2)

• Immediate success rate of mitral isthmus ablation block

  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

  immediately after the procedure

• Mitral isthmus block rate

  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

  20 minutes after the procedure

Secondary Outcomes (3)

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

  1 year

• time of operation

  immediately after the procedure

• complication

  2 weeks after the procedure

Study Arms (2)

pulsed field ablation

EXPERIMENTAL

patients receive pulsed field ablation (PFA) to achieve pulmonary vein isolation (PVI), circumferential BOX ablation around bilateral pulmonary veins, and mitral isthmus ablation.

Procedure: catheter ablation

EI-VOM

PLACEBO COMPARATOR

anhydrous alcohol is first injected into the Marshall vein, followed by radiofrequency catheter ablation to complete PVI, BOX lesion sets, and mitral isthmus ablation.

Procedure: catheter ablation

Interventions

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.

EI-VOM; pulsed field ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• lingzhiyu: lead

Related Publications (3)

• Davong B, Adelino R, Delasnerie H, Albenque JP, Combes N, Cardin C, Voglimacci-Stephanopoli Q, Combes S, Boveda S. Pulsed-Field Ablation on Mitral Isthmus in Persistent Atrial Fibrillation: Preliminary Data on Efficacy and Safety. JACC Clin Electrophysiol. 2023 Jul;9(7 Pt 2):1070-1081. doi: 10.1016/j.jacep.2023.03.021. Epub 2023 Jun 21.

  PMID: 37354173 BACKGROUND

• Sang C, Liu Q, Lai Y, Xia S, Jiang R, Li S, Guo Q, Li Q, Gao M, Guo X, Huang L, Liu N, Jiang C, Zuo S, Liu X, Li M, Ge W, Song S, Chen L, Xie S, Zou J, Chen K, Liu X, Hu H, Wang X, Zhang J, Wang Z, Wang C, He L, Jiang C, Tang R, Zhou N, Wang Y, Long D, Du X, Jiang C, Macle L, Dong J, Ma C; PROMPT-AF investigators. Pulmonary Vein Isolation With Optimized Linear Ablation vs Pulmonary Vein Isolation Alone for Persistent AF: The PROMPT-AF Randomized Clinical Trial. JAMA. 2025 Feb 4;333(5):381-389. doi: 10.1001/jama.2024.24438.

  PMID: 39556379 BACKGROUND

• Valderrabano M, Peterson LE, Swarup V, Schurmann PA, Makkar A, Doshi RN, DeLurgio D, Athill CA, Ellenbogen KA, Natale A, Koneru J, Dave AS, Giorgberidze I, Afshar H, Guthrie ML, Bunge R, Morillo CA, Kleiman NS. Effect of Catheter Ablation With Vein of Marshall Ethanol Infusion vs Catheter Ablation Alone on Persistent Atrial Fibrillation: The VENUS Randomized Clinical Trial. JAMA. 2020 Oct 27;324(16):1620-1628. doi: 10.1001/jama.2020.16195.

  PMID: 33107945 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Zhiyu Ling, PhD

CONTACT

+86 13512362075; Lingzy1977@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Clinical Professor

Study Record Dates

• First Submitted: March 1, 2025
• First Posted: March 10, 2025
• Study Start: April 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share