ARIADNE Clinical Trial

Launched by STAVROS E MOUNTANTONAKIS · Dec 18, 2024

Keywords

ClinConnect Summary

The ARIADNE Clinical Trial is studying different treatment options for people with persistent atrial fibrillation (AF), which is a heart condition that can cause irregular heartbeats and symptoms like palpitations and fatigue. Specifically, the trial will compare three different ablation strategies using a special type of catheter that can switch between two types of energy to help restore a normal heartbeat. The goal is to see if adding certain procedures, like isolating the back of the heart or ablation of a specific area near the mitral valve, can help patients stay free from AF for a full year.

To participate in this trial, you need to be between 18 and 80 years old and have been diagnosed with persistent AF that has lasted longer than 7 days but less than 12 months. You should be able to have a catheter ablation procedure and be willing to attend follow-up appointments. However, some conditions and recent medical history may prevent eligibility, such as having certain heart surgeries or conditions that affect blood clotting. If you join the trial, you can expect to receive careful monitoring and support throughout the study to help track your progress and any changes in your symptoms.

Gender

ALL

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.