ARIADNE Clinical Trial
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 isthmu
| Condition(s) | Persistent Atrial Fibrillation |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Stavros E Mountantonakis |
| Locations | Manhasset, New York, United States; New Hyde Park, New York, United States; New York, New York, United States |
| Start date | 2025-03-18 |
| NCT ID | NCT06747091 |
| Official listing | https://clinicaltrials.gov/study/NCT06747091 |