Actively Recruiting
ARIADNE Clinical Trial
Led by Stavros E Mountantonakis · Updated on 2025-09-15
60
Participants Needed
3
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ARIADNE Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Symptomatic persistent atrial fibrillation documented by a physician's note showing symptoms lasting longer than 7 days but less than 12 months with ECG evidence
- Suitable candidate for catheter ablation
- Willing and able to comply with all baseline and follow-up evaluations for the full study length
You will not qualify if you...
- Atrial fibrillation caused by electrolyte imbalance, thyroid problems, acute alcohol intoxication, or other reversible or non-cardiac causes
- Previous left atrial ablation or surgical procedure including septal closure or left atrial appendage closure
- History of valvular cardiac surgery or presence of prosthetic valve
- Any carotid artery stenting or endarterectomy
- Cardiac surgery or percutaneous intervention within 90 days before the initial procedure
- Coronary artery bypass graft surgery within 6 months before the initial procedure
- Awaiting cardiac transplant or surgery within 12 months after initial ablation
- Stroke or transient ischemic attack within 6 months before initial ablation
- Documented left atrial thrombus on imaging
- History of blood clotting or bleeding disorders
- Conditions preventing chronic anticoagulation
- Heart attack within 3 months before initial procedure
- Body mass index over 40 kg/m2
- Left atrial diameter over 55 mm
- Diagnosed atrial myxoma
- Uncontrolled or severe heart failure (NYHA class III or IV)
- Rheumatic heart disease
- Hypertrophic cardiomyopathy
- Unstable angina
- Moderate to severe mitral valve stenosis
- Severe mitral valve regurgitation
- Primary pulmonary hypertension
- Significant restrictive or obstructive lung disease or chronic respiratory condition
- Kidney failure requiring dialysis
- Severe gastroesophageal reflux disease requiring surgery or mechanical intervention
- Acute illness, active systemic infection, or sepsis
- Contraindication to both CT and MR angiography
- Significant congenital anomaly or medical problem precluding enrollment or follow-up
- Participation in other clinical studies not approved by sponsor
- Presence of intramural thrombus, tumor, or vascular abnormality preventing catheter use
- Known drug or alcohol dependency
- Life expectancy less than 12 months
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
North Shore University Hospital
Manhasset, New York, United States, 11030
Actively Recruiting
2
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Actively Recruiting
3
Kristie Coleman
New York, New York, United States, 10075
Actively Recruiting
Research Team
K
Kristie Coleman, MPH, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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