Pulsed-Field Ablation Vs. Radiofrequency Ablation CombIned with Vein of Marshall Ethanol Ablation on Mitral Isthmus Block and Clinical Outcomes in Persistent Atrial Fibrillation (PRIME-AF)
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zhiyu Ling, PhD
- Phone Number: +86 13512362075
- Email: Lingzy1977@163.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: pulsed field ablation
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 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.
|
|
Placebo Comparator: EI-VOM
anhydrous alcohol is first injected into the Marshall vein, followed by radiofrequency catheter ablation to complete PVI, BOX lesion sets, and mitral isthmus ablation.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
immediately after the procedure
|
|
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
|
20 minutes after the procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 year
|
|
time of operation
Time Frame: immediately after the procedure
|
Total operating time,Ablation time,Mitral isthmus ablation time,Radiation time;
|
immediately after the procedure
|
|
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;
|
2 weeks after the procedure
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRIME-AF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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