Comparing different ablation strategies for persistent atrial fibrillation

Adjuvant Ablation for PeRsistent AtrIal FibrillAtion Using Dual ENergy LatticE Tip Catheter: ARIADNE-Randomized Clinical Trial

This study is testing whether different types of heart procedures can help people with persistent atrial fibrillation feel better and reduce their symptoms.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Northwell Health (other)
• Locations: 3 sites (Manhasset, New York and 2 other locations)
• Trial ID: NCT06747091 on ClinicalTrials.gov

What this trial studies

This clinical trial is a prospective randomized study that aims to evaluate the efficacy of three different catheter ablation strategies in patients with persistent atrial fibrillation (AF). Participants will be randomized to receive either pulmonary vein isolation using pulsed field ablation (PFA) energy, a combination of pulmonary vein isolation and posterior wall isolation using PFA, or a more comprehensive approach that includes mitral isthmus ablation using either radiofrequency ablation (RFA) or PFA. An implantable loop recorder will be used for continuous monitoring of AF recurrence over a twelve-month period. The study seeks to determine if additional ablation strategies can lead to improved outcomes for patients suffering from persistent AF.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 80 years with symptomatic persistent atrial fibrillation documented by a physician.

Not a fit: Patients with atrial fibrillation secondary to reversible causes or those who have undergone previous left atrial ablation or certain cardiac procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with more effective treatment options for achieving freedom from atrial fibrillation.

How similar studies have performed: Other studies have shown promise in using various ablation strategies for atrial fibrillation, but this specific approach with a lattice-tip catheter is relatively novel.

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.

Where this trial is running

Manhasset, New York and 2 other locations

• North Shore University Hospital — Manhasset, New York, United States (RECRUITING)
• Long Island Jewish Medical Center — New Hyde Park, New York, United States (RECRUITING)
• Kristie Coleman — New York, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Stavros Mountantonakis, MD — Northwell Health
• Study coordinator: Kristie Coleman, MPH, RN

Conditions: Persistent Atrial Fibrillation, Pulsed Field Ablation