Back to resultsCatheter Ablation for Atrial Fibrillation in patientS With End-sTage Heart Failure and Eligibility for Heart Transplantation (CASTLE-HTx)
Primary Purpose
Heart Failure, Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Atrial fibrillation ablation
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
conventional
interventional
Arm Description
Outcomes
Primary Outcome Measures
Mortality or transplantation
composite of all-cause mortality, worsening of HF requiring a high urgent transplantation or implantation of a ventricular assist device
Secondary Outcome Measures
Full Information
NCT ID
NCT04649801
First Posted
October 7, 2020
Last Updated
May 16, 2023
Sponsor
Heart and Diabetes Center North-Rhine Westfalia
1. Study Identification
Unique Protocol Identification Number
NCT04649801
Brief Title
Catheter Ablation for Atrial Fibrillation in patientS With End-sTage Heart Failure and Eligibility for Heart Transplantation
Acronym
CASTLE-HTx
Official Title
Catheter Ablation for Atrial Fibrillation in patientS With End-sTage Heart Failure and Eligibility for Heart Transplantation (CASTLE-HTx)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
May 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heart and Diabetes Center North-Rhine Westfalia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
194 (Actual)
8. Arms, Groups, and Interventions
Arm Title
conventional
Arm Type
No Intervention
Arm Title
interventional
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Atrial fibrillation ablation
Intervention Description
Catheter ablation
Primary Outcome Measure Information:
Title
Mortality or transplantation
Description
composite of all-cause mortality, worsening of HF requiring a high urgent transplantation or implantation of a ventricular assist device
Time Frame
24 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Facility Information:
Facility Name
Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Catheter Ablation for Atrial Fibrillation in patientS With End-sTage Heart Failure and Eligibility for Heart Transplantation
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