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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

Tracking Information
First Submitted Date  ICMJE October 7, 2020
First Posted Date  ICMJE December 2, 2020
Last Update Posted Date May 17, 2023
Actual Study Start Date  ICMJE December 1, 2020
Actual Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2020)		 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Catheter Ablation for Atrial Fibrillation in patientS With End-sTage Heart Failure and Eligibility for Heart Transplantation
Official Title  ICMJE Catheter Ablation for Atrial Fibrillation in patientS With End-sTage Heart Failure and Eligibility for Heart Transplantation (CASTLE-HTx)
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Failure
  • Atrial Fibrillation
Intervention  ICMJE Procedure: Atrial fibrillation ablation
Catheter ablation
Study Arms  ICMJE
  • No Intervention: conventional
  • Active Comparator: interventional
    Intervention: Procedure: Atrial fibrillation ablation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 1, 2020)		 194
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 15, 2023
Actual Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04649801
Other Study ID Numbers  ICMJE HDZ_ER002_CS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Heart and Diabetes Center North-Rhine Westfalia
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Heart and Diabetes Center North-Rhine Westfalia
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Heart and Diabetes Center North-Rhine Westfalia
Verification Date March 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP