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Recruiting NCT07095959

Marshall Vein Ethanol Infusion in Addition to Pulsed Electric Field Ablation Versus Pulsed Electric Field Ablation Alone for Paroxysmal Atrial Fibrillation

No phase Interventional Atrial Fibrillation (AF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: vein of Marshall ethanol infusion, PVI using pulsed field ablation.
Who it may be relevant to
Registry conditions: Atrial Fibrillation (AF). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure vein of Marshall ethanol infusion
    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.
  • Procedure PVI using pulsed field ablation
    Bilateral pulmonary vein antrum ablation using a pulsed field ablation

Primary outcome measures

  • 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]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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;
  • 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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Anzhen Hospital Affiliated to Capital Medical University — Beijing

Identifiers

NCT: NCT07095959 · MARVEL-PAF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗