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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 : Completed
First Posted : December 2, 2020
Last Update Posted : May 17, 2023
Sponsor:
Information provided by (Responsible Party):
Heart and Diabetes Center North-Rhine Westfalia

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

Condition or disease Intervention/treatment Phase
Heart Failure Atrial Fibrillation Procedure: Atrial fibrillation ablation Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Primary Completion Date : December 31, 2022
Actual Study Completion Date : May 15, 2023

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Arms and Interventions
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Arm Intervention/treatment
No Intervention: conventional
Active Comparator: interventional Procedure: Atrial fibrillation ablation
Catheter ablation


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Germany
Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum
Bad Oeynhausen, Germany, 32545
Sponsors and Collaborators
Heart and Diabetes Center North-Rhine Westfalia
More Information
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Responsible Party: Heart and Diabetes Center North-Rhine Westfalia
ClinicalTrials.gov Identifier: NCT04649801    
Other Study ID Numbers: HDZ_ER002_CS
First Posted: December 2, 2020    Key Record Dates
Last Update Posted: May 17, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Atrial Fibrillation
Heart Diseases
 Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes