| NCT ID | NCT06747091 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stavros E Mountantonakis |
| Condition | Persistent Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-03-18 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-03-18 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A prospective multi-arm parallel group randomized clinical trial to compare the efficacy of three ablation strategies in patients with persistent atrial fibrillation using using a lattice-tip catheter that can switch between RFA and PFA energy. The incremental benefit of posterior wall isolation (PWI) and mitral isthmus ablation may contribute to greater freedom from atrial fibrillation at twelve months.
Eligibility Criteria
Inclusion Criteria: 1\. Symptomatic PerAF documented by (1a) a physician's note indicating symptoms consistent with AF sustained longer than 7 days but less than 12 months; AND electrocardiographic evidence 2\. . Suitable candidate for catheter ablation. 3\. . Adults aged 18 - 80 years. 4\. . Willing and able to comply with all baseline and follow-up evaluations for the full length of the study. Exclusion Criteria: 1. AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or other reversible or non-cardiac cause. 2. Previous left atrial ablation or surgical procedure (including septal closure or left atrial appendage closure). 3. Valvular cardiac surgical/percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve). 4. Any carotid stenting or endarterectomy. 5. Any cardiac procedure (surgical or percutaneous) or percutaneous coronary intervention within the 90 days prior to the initial procedure. 6. Coronary artery bypass graft (CABG) procedure within the 6 months prior to the initial procedure. 7. Awaiting cardiac transplantation or other cardiac surgery within the 12 months following the initial ablation procedure. 8. Documented thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the initial ablation procedure. 9. Documented left atrial thrombus on imaging. 10. History of blood clotting or bleeding abnormalities. 11. Any condition contraindicating chronic anticoagulation. 12. Myocardial infarction (MI) within the 3 months (90 days) prior to the initial procedure. 13. Body mass index \>40 kg/m2. 14. Left atrial diameter \>55 mm (anterioposterior). 15. Diagnosed atrial myxoma. 16. Uncontrolled heart failure or NYHA Class III or IV heart failure. 17. Rheumatic heart disease. 18. Hypertrophic cardiomyopathy. 19. Unstable angina. 20. Moderate to severe mitral valve stenosis. 21. Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2). 22. Primary pulmonary hypertension. 23. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition. 24. Renal failure requiring dialysis. 25. History of severe Gastroesophageal Reflux Disease (GERD) requiring surgical and/or mechanical intervention. 26. Acute illness, active systemic infection, or sepsis. 27. Contraindication to both computed tomography and magnetic resonance angiography. 28. Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would impact the scientific soundness of the clinical study results. 29. Current or anticipated participation in any other clinical study of a drug, device, or biologic during the duration of the study not pre-approved by the Sponsor. 30. Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation. 31. Known drug or alcohol dependency. 32. Life expectancy less than 12 months.
Contact & Investigator
Stavros Mountantonakis, MD
PRINCIPAL INVESTIGATOR
Northwell Health
Frequently Asked Questions
Who can join the NCT06747091 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Persistent Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06747091 currently recruiting?
Yes, NCT06747091 is actively recruiting participants. Contact the research team at kcoleman1@Northwell.edu for enrollment information.
Where is the NCT06747091 trial being conducted?
This trial is being conducted at Manhasset, United States, New Hyde Park, United States, New York, United States.
Who is sponsoring the NCT06747091 clinical trial?
NCT06747091 is sponsored by Stavros E Mountantonakis. The principal investigator is Stavros Mountantonakis, MD at Northwell Health. The trial plans to enroll 60 participants.
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