NCT06866704Not yet recruiting
Pulsed-Field Ablation vs. Radiofrequency Ablation CombIned With Vein of Marshall Ethanol Ablation on Mitral Isthmus Block and Clinical Outcomes in Persistent Atrial Fibrillation
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
Source: ClinicalTrials.gov · Last updated 11 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 154 (estimated)
- First submitted
- 1 Mar 2025
- Start date
- 1 Apr 2025
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- lingzhiyu
- Diseases
- Atrial fibrillation
- NCT number
- NCT06866704
What you commit to
- Study type: Interventional
- Planned participants: 154
- From 1 Apr 2025 to the primary completion date, 31 Dec 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- History of atrial fibrillation ablation;
- History of heart transplantation, complex congenital heart disease, or rheumatic heart disease;
Other
- 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;
Who the study is looking for
- Persistent atrial fibrillation;
- Ejection fraction \>30%;
- NYHA functional class I-III;
- Left atrial diameter \<55 mm on echocardiography;
- Signed informed consent form;
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.