Clinical trial NCT06747091: ARIADNE Clinical Trial
Official title: Adjuvant Ablation for PeRsistent AtrIal FibrillAtion Using Dual ENergy LatticE Tip Catheter: ARIADNE-Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Persistent Atrial Fibrillation
Keywords: Pulsed Field Ablation
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This is a prospective randomized clinical trial. Patients will undergo catheter ablation for persistent AF using a lattice-tip catheter that can switch between RFA and PFA energy. Enrolled patients will be randomized to one of three ablation strategies:

1. Pulmonary vein isolation using PFA energy
2. Pulmonary vein isolation and posterior wall isolation using PFA energy
3. Pulmonary vein isolation and posterior wall isolation (PFA) and mitral isthmus ablation using RFA or PFA energy.

Patients will receive an implantable loop recorder prior to, during or post index ablation procedure for continuous monitoring for clinical recurrence of AF/AT/AFL

Eligibility criteria: 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:

1. AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or other reversible or non-cardiac cause.
2. Previous left atrial ablation or surgical procedure (including septal closure or left atrial appendage closure).
3. Valvular cardiac surgical/percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
4. Any carotid stenting or endarterectomy.
5. Any cardiac procedure (surgical or percutaneous) or percutaneous coronary intervention within the 90 days prior to the initial procedure.
6. Coronary artery bypass graft (CABG) procedure within the 6 months prior to the initial procedure.
7. Awaiting cardiac transplantation or other cardiac surgery within the 12 months following the initial ablation procedure.
8. Documented thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the initial ablation procedure.
9. Documented left atrial thrombus on imaging.
10. History of blood clotting or bleeding abnormalities.
11. Any condition contraindicating chronic anticoagulation.
12. Myocardial infarction (MI) within the 3 months (90 days) prior to the initial procedure.
13. Body mass index \>40 kg/m2.
14. Left atrial diameter \>55 mm (anterioposterior).
15. Diagnosed atrial myxoma.
16. Uncontrolled heart failure or NYHA Class III or IV heart failure.
17. Rheumatic heart disease.
18. Hypertrophic cardiomyopathy.
19. Unstable angina.
20. Moderate to severe mitral valve stenosis.
21. Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2).
22. Primary pulmonary hypertension.
23. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.
24. Renal failure requiring dialysis.
25. History of severe Gastroesophageal Reflux Disease (GERD) requiring surgical and/or mechanical intervention.
26. Acute illness, active systemic infection, or sepsis.
27. Contraindication to both computed tomography and magnetic resonance angiography.
28. 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.
29. 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.
30. Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation.
31. Known drug or alcohol dependency.
32. Life expectancy less than 12 months.

Primary outcomes:
measure: Percent of subjects free from primary effectiveness failure
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: New York
country: United States
facility: Kristie Coleman
state: New York
Study officials:
affiliation: Northwell Health
name: Stavros Mountantonakis, MD
role: PRINCIPAL_INVESTIGATOR
References: