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New treatment option for Persistent Atrial Fibrillation
Official title ARIADNE Clinical Trial
ClinicalTrials.gov ID: NCT06747091
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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.
You likely can't join 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...
- 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.
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Manhasset, New York, United States
- New Hyde Park, New York, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Manhasset, New York, United States; New Hyde Park, New York, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.