ARIADNE Clinical Trial

Recruiting now · Not applicable

Conditions studied: Persistent Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT06747091

Run by

Stavros E Mountantonakis

People needed

60

Starts

2025-03-18

Expected to finish

2027-03-01

Last updated by the study team

2025-09-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• . Suitable candidate for catheter ablation.
• . Adults aged 18 - 80 years.
• . Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.

You may not qualify if…

• AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or other reversible or non-cardiac cause.
• Previous left atrial ablation or surgical procedure (including septal closure or left atrial appendage closure).
• Valvular cardiac surgical/percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
• Any carotid stenting or endarterectomy.
• Any cardiac procedure (surgical or percutaneous) or percutaneous coronary intervention within the 90 days prior to the initial procedure.
• Coronary artery bypass graft (CABG) procedure within the 6 months prior to the initial procedure.
• Awaiting cardiac transplantation or other cardiac surgery within the 12 months following the initial ablation procedure.
• Documented thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the initial ablation procedure.
• Documented left atrial thrombus on imaging.
• History of blood clotting or bleeding abnormalities.
• Any condition contraindicating chronic anticoagulation.
• Myocardial infarction (MI) within the 3 months (90 days) prior to the initial procedure.
• Body mass index >40 kg/m2.
• Left atrial diameter >55 mm (anterioposterior).
• Diagnosed atrial myxoma.
• Uncontrolled heart failure or NYHA Class III or IV heart failure.
• Rheumatic heart disease.
• Hypertrophic cardiomyopathy.
• Unstable angina.
• Moderate to severe mitral valve stenosis.
• Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2).
• Primary pulmonary hypertension.
• Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.
• Renal failure requiring dialysis.
• History of severe Gastroesophageal Reflux Disease (GERD) requiring surgical and/or mechanical intervention.

Where it is running

• North Shore University Hospital — Manhasset, New York, United States (enrolling)
• Long Island Jewish Medical Center — New Hyde Park, New York, United States (enrolling)
• Kristie Coleman — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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