Atrial Fibrillation (AF)MARVEL-PAFNCT07095959
Marshall Vein Ethanol Infusion in Addition to Pulsed Electric Field Ablation Versus Pulsed Electric Field Ablation Alone for Paroxysmal Atrial Fibrillation
A study testing vein of Marshall ethanol infusion and PVI using pulsed field ablation in people with Atrial Fibrillation (AF), run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
The Marvel-PAF trial is an investigator initiated, multi-center, open-label, randomized trial, which aims to compare the effectiveness of vein of Marshall in addition to pulmonary vein isolation using pulsed field ablation in the treatment of paroxysmal atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- vein of Marshall ethanol infusion and PVI using pulsed field ablation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2025to 1 Sep 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years;
- With symptomatic* paroxysmal AF;
- Undergoing first AF ablation;
- At least one AF lasting over 30s documented by 12-lead ECG, Holter, or other rhythm monitoring device in the past 12 months;
- Able to understand the purpose of the study, willing to receive randomization of the ablation strategy, and able to be followed up as required, voluntarily participate in the study and signed a written informed consent.
- Symptoms include but not restricted to palpitations, dizziness, fatigue, or shortness of breath and chest discomfort
Who cannot join
- Diagnosed with persistent atrial fibrillation or duration of atrial fibrillation >7 days;
- Thrombosis in the heart cavity;
- Contraindications to oral anticoagulants including the presence of a history of heparin-induced thrombocytopenia;
- Transient/reversible atrial fibrillation due to electrolyte disorders, thyroid disease or other non-cardiac-related causes;
- Acute coronary syndrome in the past 3 months or coronary intervention or coronary artery bypass treatment;
- Stroke or transient ischemic attacks (TIA) in the past 3 months;
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- History of cardiac surgery or other surgical history involving left atrium, such as previous left atrial catheter ablation, atrial septal defect repair, etc.;
- History of previous severe valvular disease (severe mitral stenosis or regurgitation), congenital heart disease, hypertrophic cardiomyopathy or dilated cardiomyopathy;
- TEE examination in the past 12 months showed that the left atrium diameter of the parasternal long axis section was ≥55mm;
- Other factors that are not suitable for surgery (such as history of organ transplant surgery or ongoing evaluation of organ transplant surgery, life expectancy less than 1 year, uncontrolled cancer, pregnancy, breastfeeding, or planning to get pregnant, etc.);
- Other patients who were not suitable for enrollment in this study after the investigator's evaluation;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yiwei Lai contact
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100029
Caihua Sang, +86 010-81992280, sch9613070@sina.com
About this study
The Marvel-PAF trial is an investigator initiated, multi-center, open-label, randomized trial, which aims to compare the effectiveness of vein of Marshall in addition to pulmonary vein isolation using pulsed field ablation in the treatment of paroxysmal atrial fibrillation. The primary endpoint is any atrial arrhythmias lasting ≥30s without AAD during 12 months after procedure excluding the 2-months blanking period.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- vein of Marshall ethanol infusion, PVI using pulsed field ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vein of Marshall ethanol infusionProcedure or surgery
After PFA, the coronary sinus venography will be acquired in search of VOM ostium. Then an over-the-wire balloon will be sent into the VOM and deflated with 4-6 atm. Selective VOM venography will be performed, followed by injection of 10ml 95% ethanol into the VOM.
PVI using pulsed field ablationProcedure or surgery
Bilateral pulmonary vein antrum ablation using a pulsed field ablation
| Study group | Role | What they receive |
|---|---|---|
| PFA-PVI + EIVOM group | Experimental | PVI will be performed with PFA first, then EIVOM will be performed to achieve potential cardiac autonomous nerve modulation while reinforce LPV isolation. Receives: Procedure: vein of Marshall ethanol infusion; Procedure: PVI using pulsed field ablation |
| PFA-PVI group | Active comparator | PVI will be performed with PFA only Receives: Procedure: PVI using pulsed field ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any atrial arrhythmias lasting ≥30s without AAD during 12 months after procedure excluding the 2-months blanking period
Measured: 12 months after procedure excluding the 2-month blanking period
Secondary outcomes (6)
Any atrial arrhythmias lasting ≥30s with or without AAD during 12 months after procedure excluding the 2-months blanking period
Measured: 12 months after procedure excluding the 2-months blanking period
Any atrial flutter/atrial tachycardia lasting ≥30s during 12 months after procedure excluding the 2-months blanking period
Measured: 12 months after procedure excluding the 2-months blanking period
Any atrial arrhythmias after multiple ablation with or without AADs
Measured: 12 months after first procedure excluding the 2-months blanking period
AF burden
Total AF/AFL time devided by total monitoring time
Measured: 12 months after procedure excluding the 2-months blanking period
procedural complications
Measured: 30 days after the procedure
Change in quality of life
Assessed by AFEQT scale
Measured: at baseline and 12 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start31 Jul 2025
- Primary completion10 Jul 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caihua Sang, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095959
- Sponsor's protocol ID
- MARVEL-PAF
- Acronym
- MARVEL-PAF
- Status last verified
- Jul 2025
- First submitted
- 22 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will be shared only upon reasonable request to the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Marshall Vein Ethanol Infusion in Addition to Pulsed Electric Field Ablation Versus Pulsed Electric Field Ablation Alone for Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07095959
- Acronym / sponsor ID
- MARVEL-PAF / MARVEL-PAF
- Conditions
- Atrial Fibrillation (AF)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- 10 Jul 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 31 Jul 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.
The Marvel-PAF trial is an investigator initiated, multi-center, open-label, randomized trial, which aims to compare the effectiveness of vein of Marshall in addition to pulmonary vein isolation using pulsed field ablation in the treatment of paroxysmal atrial fibrillation. The primary endpoint is any atrial arrhythmias lasting ≥30s without AAD during 12 months after procedure excluding the 2-months blanking period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PFA-PVI + EIVOM group | Experimental | Procedure: vein of Marshall ethanol infusion, Procedure: PVI using pulsed field ablationPVI will be performed with PFA first, then EIVOM will be performed to achieve potential cardiac autonomous nerve modulation while reinforce LPV isolation. |
| PFA-PVI group | Active comparator | Procedure: PVI using pulsed field ablationPVI will be performed with PFA only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age over 18 years;
- With symptomatic* paroxysmal AF;
- Undergoing first AF ablation;
- At least one AF lasting over 30s documented by 12-lead ECG, Holter, or other rhythm monitoring device in the past 12 months;
- Able to understand the purpose of the study, willing to receive randomization of the ablation strategy, and able to be followed up as required, voluntarily participate in the study and signed a written informed consent.
Key exclusion criteria (11 listed)
- Diagnosed with persistent atrial fibrillation or duration of atrial fibrillation >7 days;
- Thrombosis in the heart cavity;
- Contraindications to oral anticoagulants including the presence of a history of heparin-induced thrombocytopenia;
- Transient/reversible atrial fibrillation due to electrolyte disorders, thyroid disease or other non-cardiac-related causes;
- Acute coronary syndrome in the past 3 months or coronary intervention or coronary artery bypass treatment;
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 |
|---|---|---|
| vein of Marshall ethanol infusionAfter PFA, the coronary sinus venography will be acquired in search of VOM ostium. Then an over-the-wire balloon will be sent into the VOM and deflated with 4-6 atm. Selective VOM venography will be performed, followed by injection of 10ml 95% ethanol into the VOM. | Procedure or surgery | PFA-PVI + EIVOM group |
| PVI using pulsed field ablationBilateral pulmonary vein antrum ablation using a pulsed field ablation | Procedure or surgery | PFA-PVI + EIVOM group, PFA-PVI group |
Primary outcome
Any atrial arrhythmias lasting ≥30s without AAD during 12 months after procedure excluding the 2-months blanking period
Time frame: 12 months after procedure excluding the 2-month blanking period
6 secondary outcomes
Any atrial arrhythmias lasting ≥30s with or without AAD during 12 months after procedure excluding the 2-months blanking period
Time frame: 12 months after procedure excluding the 2-months blanking period
Any atrial flutter/atrial tachycardia lasting ≥30s during 12 months after procedure excluding the 2-months blanking period
Time frame: 12 months after procedure excluding the 2-months blanking period
Any atrial arrhythmias after multiple ablation with or without AADs
Time frame: 12 months after first procedure excluding the 2-months blanking period
AF burden
Time frame: 12 months after procedure excluding the 2-months blanking period
procedural complications
Time frame: 30 days after the procedure
Change in quality of life
Time frame: at baseline and 12 months after 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 7 Aug 2025.
- Individual participant dataSharing planned: No. Individual data will be shared only upon reasonable request to the principal investigator
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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.
Yiwei Lai contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vein of Marshall ethanol infusion and PVI using pulsed field ablation in people with Atrial Fibrillation (AF), run by Beijing Anzhen Hospital at 1 site in China.
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 6 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Caihua Sang, MD (+86 010-81992280, sch9613070@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any atrial arrhythmias lasting ≥30s without AAD during 12 months after procedure excluding the 2-months blanking period (time frame: 12 months after procedure excluding the 2-month blanking period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2025.