Atrial Fibrillation (AF)PRIME-AFNCT06866704
Pulsed-Field Ablation vs. Radiofrequency Ablation CombIned With Vein of Marshall Ethanol Ablation on Mitral Isthmus Block and Clinical Outcomes in Persistent Atrial Fibrillation
A study testing catheter ablation in people with Atrial Fibrillation (AF), run by lingzhiyu.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- catheter ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persistent atrial fibrillation;
- Ejection fraction >30%;
- NYHA functional class I-III;
- Left atrial diameter <55 mm on echocardiography;
- Signed informed consent form;
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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)
- Being tested
- catheter ablation
- Keywords
- persistent atrial fibrillation, pulsed field ablation, EI-VOM
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catheter ablationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
The incidence of atrial arrhythmias (tachycardia, atrial flutter, atrial fibrillation) over 30 seconds without antiarrhythmic drugs was followed up for 12 months.
Measured: 1 year
time of operation
Total operating time,Ablation time,Mitral isthmus ablation time,Radiation time;
Measured: immediately after the procedure
complication
Incidence of pericardial tamponade, acute heart failure, pericardial effusion, pleural effusion; Puncture complications; Incidence of cerebral infarction and TIA; Death;
Measured: 2 weeks after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- lingzhiyu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, lingzhiyu, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866704
- Sponsor's protocol ID
- PRIME-AF
- Acronym
- PRIME-AF
- Status last verified
- Mar 2025
- First submitted
- 1 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 37354173Sang 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.
PubMed 39556379Valderrabano 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.
PubMed 33107945
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06866704
- Acronym / sponsor ID
- PRIME-AF / PRIME-AF
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- persistent atrial fibrillation, pulsed field ablation, EI-VOM
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- lingzhiyuUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pulsed field ablation | Experimental | Procedure: catheter ablationpatients receive pulsed field ablation (PFA) to achieve pulmonary vein isolation (PVI), circumferential BOX ablation around bilateral pulmonary veins, and mitral isthmus ablation. |
| EI-VOM | Placebo comparator | Procedure: catheter ablationanhydrous alcohol is first injected into the Marshall vein, followed by radiofrequency catheter ablation to complete PVI, BOX lesion sets, and mitral isthmus ablation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Persistent atrial fibrillation;
- Ejection fraction >30%;
- NYHA functional class I-III;
- Left atrial diameter <55 mm on echocardiography;
- Signed informed consent form;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| catheter ablationIn 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. | Procedure or surgery | EI-VOM, pulsed field ablation |
Primary outcome
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
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
3 secondary outcomes
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
time of operation
Time frame: immediately after the procedure
complication
Time frame: 2 weeks after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Results publication: PubMed 37354173Davong 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.
- Results publication: PubMed 39556379Sang 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.
- Results publication: PubMed 33107945Valderrabano 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing catheter ablation in people with Atrial Fibrillation (AF), run by lingzhiyu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhiyu Ling, PhD (+86 13512362075, Lingzy1977@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate success rate of mitral isthmus ablation block (time frame: immediately after the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06866704, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.