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

Sponsor
Heart and Diabetes Center North-Rhine Westfalia (Other)
Overall Status
Recruiting
CT.gov ID
NCT04649801
Collaborator
(none)
194
Enrollment
1
Location
2
Arms
26.9
Anticipated Duration (Months)
7.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: Atrial fibrillation ablation
 N/A

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

Study Type:
Interventional
Anticipated 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 :
Dec 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: conventional
Active Comparator: interventional

Procedure: Atrial fibrillation ablation
Catheter ablation

Outcome Measures

Primary Outcome Measures

  1. Mortality or transplantation [24 months]

    composite of all-cause mortality, worsening of HF requiring a high urgent transplantation or implantation of a ventricular assist device

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum Bad Oeynhausen Germany 32545

Sponsors and Collaborators

  • Heart and Diabetes Center North-Rhine Westfalia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Heart and Diabetes Center North-Rhine Westfalia
ClinicalTrials.gov Identifier:
NCT04649801
Other Study ID Numbers:
  • HDZ_ER002_CS
First Posted:
Dec 2, 2020
Last Update Posted:
Sep 20, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Heart Failure
Atrial Fibrillation

Study Results

No Results Posted as of Sep 20, 2021