RECRUITING

ARIADNE Clinical Trial

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Conditions

Persistent Atrial FibrillationPulsed Field Ablation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-18
Study Completion:2026-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06747091

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Symptomatic PerAF documented by
  2. 2. . Suitable candidate for catheter ablation.
  3. 3. . Adults aged 18 - 80 years.
  4. 4. . Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.
  1. 1. AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or other reversible or non-cardiac cause.
  2. 2. Previous left atrial ablation or surgical procedure (including septal closure or left atrial appendage closure).
  3. 3. Valvular cardiac surgical/percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
  4. 4. Any carotid stenting or endarterectomy.
  5. 5. Any cardiac procedure (surgical or percutaneous) or percutaneous coronary intervention within the 90 days prior to the initial procedure.
  6. 6. Coronary artery bypass graft (CABG) procedure within the 6 months prior to the initial procedure.
  7. 7. Awaiting cardiac transplantation or other cardiac surgery within the 12 months following the initial ablation procedure.
  8. 8. Documented thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the initial ablation procedure.
  9. 9. Documented left atrial thrombus on imaging.
  10. 10. History of blood clotting or bleeding abnormalities.
  11. 11. Any condition contraindicating chronic anticoagulation.
  12. 12. Myocardial infarction (MI) within the 3 months (90 days) prior to the initial procedure.
  13. 13. Body mass index \>40 kg/m2.
  14. 14. Left atrial diameter \>55 mm (anterioposterior).
  15. 15. Diagnosed atrial myxoma.
  16. 16. Uncontrolled heart failure or NYHA Class III or IV heart failure.
  17. 17. Rheumatic heart disease.
  18. 18. Hypertrophic cardiomyopathy.
  19. 19. Unstable angina.
  20. 20. Moderate to severe mitral valve stenosis.
  21. 21. Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2).
  22. 22. Primary pulmonary hypertension.
  23. 23. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.
  24. 24. Renal failure requiring dialysis.
  25. 25. History of severe Gastroesophageal Reflux Disease (GERD) requiring surgical and/or mechanical intervention.
  26. 26. Acute illness, active systemic infection, or sepsis.
  27. 27. Contraindication to both computed tomography and magnetic resonance angiography.
  28. 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. 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. 30. Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation.
  31. 31. Known drug or alcohol dependency.
  32. 32. Life expectancy less than 12 months.

Contacts and Locations

Study Contact

Kristie Coleman, MPH, RN
CONTACT
2124346500
kcoleman1@Northwell.edu

Principal Investigator

Stavros Mountantonakis, MD
PRINCIPAL_INVESTIGATOR
Northwell Health

Study Locations (Sites)

North Shore University Hospital
Manhasset, New York, 11030
United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
United States
Kristie Coleman
New York, New York, 10075
United States

Collaborators and Investigators

Sponsor: Stavros E Mountantonakis

  • Stavros Mountantonakis, MD, PRINCIPAL_INVESTIGATOR, Northwell Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-18
Study Completion Date2026-01-01

Study Record Updates

Study Start Date2025-03-18
Study Completion Date2026-01-01

Terms related to this study

Keywords Provided by Researchers

  • Pulsed Field Ablation

Additional Relevant MeSH Terms

  • Persistent Atrial Fibrillation