ARIADNE Clinical Trial

Korábbi kezelés

• Previous left atrial ablation or surgical procedure (including septal closure or left atrial appendage closure).
• Any cardiac procedure (surgical or percutaneous) or percutaneous coronary intervention within the 90 days prior to the initial procedure.
• Coronary artery bypass graft (CABG) procedure within the 6 months prior to the initial procedure.
• Documented thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the initial ablation procedure.
• Myocardial infarction (MI) within the 3 months (90 days) prior to the initial procedure.
• 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.
• Known drug or alcohol dependency.

Más betegség

• AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or other reversible or non-cardiac cause.
• Valvular cardiac surgical/percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
• Awaiting cardiac transplantation or other cardiac surgery within the 12 months following the initial ablation procedure.
• History of blood clotting or bleeding abnormalities.
• Any condition contraindicating chronic anticoagulation.
• Uncontrolled heart failure or NYHA Class III or IV heart failure.
• Rheumatic heart disease.
• Unstable angina.
• Primary pulmonary hypertension.
• Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.
• Renal failure requiring dialysis.
• History of severe Gastroesophageal Reflux Disease (GERD) requiring surgical and/or mechanical intervention.
• Acute illness, active systemic infection, or sepsis.

Egyéb

• Any carotid stenting or endarterectomy.
• Documented left atrial thrombus on imaging.
• Body mass index >40 kg/m2.
• Left atrial diameter >55 mm (anterioposterior).
• Diagnosed atrial myxoma.
• Hypertrophic cardiomyopathy.
• Moderate to severe mitral valve stenosis.
• Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2).
• Contraindication to both computed tomography and magnetic resonance angiography.
• 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.
• Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation.
• Life expectancy less than 12 months.

• 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
• . Suitable candidate for catheter ablation.
• . Adults aged 18 - 80 years.
• . Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.