Actively Recruiting
Adjuvant Ablation for Persistent Atrial Fibrillation Using Dual Energy Lattice Tip Catheter: ARIADNE-Randomized Clinical Trial
Led by Stavros E Mountantonakis · Updated on 2025-09-15
60
Participants Needed
3
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating three different catheter ablation strategies for patients with persistent atrial fibrillation using a special lattice-tip catheter that can switch between radiofrequency ablation (RFA) and pulsed field ablation (PFA) energy. The study aims to determine if adding posterior wall isolation and mitral isthmus ablation improves freedom from atrial fibrillation over 12 months. This randomized clinical trial compares these approaches to find the most effective treatment combinations for this heart rhythm condition. Patients will be randomly assigned to one of three treatment groups: pulmonary vein isolation using PFA energy alone; pulmonary vein isolation plus posterior wall isolation using PFA energy; or pulmonary vein isolation combined with posterior wall isolation using PFA and mitral isthmus ablation with either RFA or PFA energy. An implantable loop recorder will be placed before, during, or shortly after the ablation procedure to continuously monitor for any return of atrial fibrillation, atrial tachycardia, or atrial flutter. Participants will be monitored for 12 months with regular evaluations to assess treatment success, defined mainly by freedom from primary effectiveness failure. The study includes baseline and follow-up assessments including implantable device monitoring. Safety and outcome data will help understand the benefits and risks of the different ablation strategies. The total study duration for each participant is one year following the ablation procedure.
CONDITIONS
Brief Title
ARIADNE Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Symptomatic persistent atrial fibrillation lasting longer than 7 days but less than 12 months, confirmed by physician and ECG
- Suitable candidate for catheter ablation
- Willing and able to comply with all baseline and follow-up evaluations for the full length of the study
You will not qualify if you...
- Atrial fibrillation caused by reversible or non-cardiac factors like electrolyte imbalance or thyroid disease
- Previous left atrial ablation or heart surgery including septal or left atrial appendage closure
- History of heart valve surgery or presence of prosthetic valve
- Carotid artery stenting or endarterectomy
- Cardiac procedures or coronary intervention within 90 days before study
- Coronary artery bypass graft surgery within 6 months before study
- Planned heart transplant or cardiac surgery within 12 months following ablation
- Stroke or transient ischemic attack within 6 months prior to ablation
- Left atrial thrombus on imaging
- Blood clotting or bleeding disorders
- Contraindication to long-term anticoagulation
- Heart attack within 3 months prior to ablation
- Body mass index over 40 kg/m2
- Enlarged left atrial diameter over 55 mm
- Diagnosed atrial myxoma
- Uncontrolled or advanced heart failure (NYHA Class III or IV)
- Rheumatic heart disease or hypertrophic cardiomyopathy
- Unstable angina or severe mitral valve disease
- Primary pulmonary hypertension
- Significant lung disease or chronic respiratory condition
- Kidney failure requiring dialysis
- Severe gastroesophageal reflux disease needing surgery
- Active infection or sepsis
- Unable to have CT or MR angiography
- Significant congenital or medical problems precluding study participation
- Participation in other clinical studies without approval
- Intramural thrombus, tumor, or vascular access issues
- Known drug or alcohol dependency
- Life expectancy less than 12 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single procedure with recovery period
Participants undergo catheter ablation using a lattice-tip catheter with one of three ablation strategies involving pulmonary vein isolation and additional ablations.
1 procedure visit and follow-up visits for monitoring
Duration - Up to 12 months
Participants receive continuous monitoring for clinical recurrence of atrial fibrillation using an implantable loop recorder after the ablation procedure.
Regular follow-up visits during 12 months
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
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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