NCT06747091 · Stavros E Mountantonakis
ARIADNE Clinical Trial
(ARIADNE RCT)
What this study is about
A forward-looking multi-treatment group$1 parallel group randomly assigned clinical trial to compare the effectiveness of three ablation strategies in patients with persistent atrial fibrillation using using a lattice-tip catheter that can switch between RFA and PFA energy.
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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.
- Acute illness, active systemic infection, or sepsis.
- Contraindication to both computed tomography and magnetic resonance angiography.
- 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.
- 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.
- Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation.
- Known drug or alcohol dependency.
- Life expectancy less than 12 months.
Where
- Manhasset, New York
- New Hyde Park, New York
- New York, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 15, 2025 · Source of record for eligibility and locations