Heart Failure Clinical Trial
— CASTLE-HTxOfficial title:
Catheter Ablation for Atrial Fibrillation in patientS With End-sTage Heart Failure and Eligibility for Heart Transplantation (CASTLE-HTx)
Verified date | March 2023 |
Source | Heart and Diabetes Center North-Rhine Westfalia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
CASTLE-HTx will determine if AF ablation has beneficial effects on mortality in patients with end stage HF who are eligible for HTx
Status | Completed |
Enrollment | 194 |
Est. completion date | May 15, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. 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). 2. Eligible for heart transplantation due to end-stage heart failure 3. LV dysfunction with left ventricular ejection fraction = 35% (measured in the last 6 weeks prior to enrollment). 4. NYHA class = II. 5. Indication for ICD therapy due to primary prevention. 6. Dual chamber ICD with Home Monitoring capabilities already implanted. 7. The patient is willing and able to comply with the protocol and has provided written informed consent. 8. Sufficient GPRS-network coverage in the patient's area. 9. Age = 18 years. Exclusion Criteria: 1. Documented left atrial diameter > 6 cm (parasternal long-axis view) 2. Contraindication for chronic anticoagulation therapy or heparin 3. Previous left heart ablation procedure for atrial fibrillation 4. Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 2 months prior to enrollment 5. Untreated hypothyroidism or hyperthyroidism 6. Enrollment in another investigational drug or device study 7. Indication for cardiac resynchronization therapy 8. Woman currently pregnant, breastfeeding, or not using reliable contraceptive measures during fertility age 9. Mental or physical inability to participate in the study 10. Listed as "high urgent" for heart transplantation 11. Cardiac assist device implanted 12. Planned cardiovascular intervention 13. Life expectancy = 12 month 14. Uncontrolled hypertension 15. Requirement for dialysis due to end-stage renal failure 16. Participation in another telemonitoring concept |
Country | Name | City | State |
---|---|---|---|
Germany | Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum | Bad Oeynhausen |
Lead Sponsor | Collaborator |
---|---|
Heart and Diabetes Center North-Rhine Westfalia |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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