Catheter Ablation for Atrial Fibrillation in patientS With End-sTage Heart Failure and Eligibility for Heart Transplantation

Study Overview
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Brief Summary
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CASTLE-HTx will determine if AF ablation has beneficial effects on mortality in patients with end stage HF who are eligible for HTx

Detailed Description
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CASTLE-HTx is a randomized evaluation of ablative treatment of AF in patients with severe left ventricular dysfunction who are candidates and eligible for HTx. The primary endpoint is the composite of all-cause mortality, worsening of HF requiring a high urgent transplantation or LVAD implantation. The secondary study endpoints are all-cause mortality, cardiovascular mortality, cerebrovascular accidents, worsening of HF requiring unplanned hospitalization, AF burden reduction, unplanned hospitalization due to cardiovascular reason, all-cause hospitalization, QoL, number of delivered implantable cardioverter-defibrillator (ICD) therapies, time to first ICD therapy, number of device-detected ventricular tachycardia/ventricular fibrillation episodes, LV function, exercise tolerance, and percentage of right ventricular pacing. Ventricular myocardial tissue will be obtained from patients who will undergo LVAD implantation or HTx to assess the effect of catheter ablation on human HF myocardium.

Official Title
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Catheter Ablation for Atrial Fibrillation in patientS With End-sTage Heart Failure and Eligibility for Heart Transplantation (CASTLE-HTx)

Conditions
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Heart Failure, Atrial Fibrillation

Intervention / Treatment
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* Procedure: Atrial fibrillation ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic paroxysmal or persistent AF (paroxysmal: ≥2 symptomatic or one documented AF episode lasting 30 seconds or more in the last 3 months; persistent: ≥1 documented episode in the last 3 months). Eligible for heart transplantation due to end-stage heart failure LV dysfunction with left ventricular ejection fraction ≤ 35% (measured in the last 6 weeks prior to enrollment). NYHA class ≥ II. Indication for ICD therapy due to primary prevention. Dual chamber ICD with Home Monitoring capabilities already implanted. The patient is willing and able to comply with the protocol and has provided written informed consent. Sufficient GPRS-network coverage in the patient's area. Age ≥ 18 years. Exclusion Criteria: Documented left atrial diameter > 6 cm (parasternal long-axis view) Contraindication for chronic anticoagulation therapy or heparin Previous left heart ablation procedure for atrial fibrillation Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 2 months prior to enrollment Untreated hypothyroidism or hyperthyroidism Enrollment in another investigational drug or device study Indication for cardiac resynchronization therapy Woman currently pregnant, breastfeeding, or not using reliable contraceptive measures during fertility age Mental or physical inability to participate in the study Listed as high urgent for heart transplantation Cardiac assist device implanted Planned cardiovascular intervention Life expectancy ≤ 12 month Uncontrolled hypertension Requirement for dialysis due to end-stage renal failure Participation in another telemonitoring concept

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: conventional<br> | |
| Active Comparator: interventional<br> | Procedure: Atrial fibrillation ablation<br>* Catheter ablation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality or transplantation | composite of all-cause mortality, worsening of HF requiring a high urgent transplantation or implantation of a ventricular assist device | 24 months |