Catheter Ablation for Atrial Fibrillation in patientS With End-sTage Heart Failure and Eligibility for Heart Transplantation (CASTLE-HTx)
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|ClinicalTrials.gov Identifier: NCT04649801|
Recruitment Status : Recruiting
First Posted : December 2, 2020
Last Update Posted : September 20, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Atrial Fibrillation||Procedure: Atrial fibrillation ablation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||194 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Catheter Ablation for Atrial Fibrillation in patientS With End-sTage Heart Failure and Eligibility for Heart Transplantation (CASTLE-HTx)|
|Actual Study Start Date :||December 1, 2020|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||March 2023|
|No Intervention: conventional|
|Active Comparator: interventional||
Procedure: Atrial fibrillation ablation
- Mortality or transplantation [ Time Frame: 24 months ]composite of all-cause mortality, worsening of HF requiring a high urgent transplantation or implantation of a ventricular assist device
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04649801
|Contact: Christian Sohns, MD||49 5731 firstname.lastname@example.org|
|Contact: Astrid Kleemeyer||49 5731 email@example.com|
|Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum||Recruiting|
|Bad Oeynhausen, Germany, 32545|
|Contact: Astrid R Kleemeyer +49495731971258 firstname.lastname@example.org|
|Principal Investigator: Christian Sohns, MD|
|Responsible Party:||Heart and Diabetes Center North-Rhine Westfalia|
|Other Study ID Numbers:||
|First Posted:||December 2, 2020 Key Record Dates|
|Last Update Posted:||September 20, 2021|
|Last Verified:||September 2021|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|