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

Heart Failure Clinical Trial

— CASTLE-HTx  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04649801
• Other study ID #: HDZ_ER002_CS
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: May 15, 2023

Study information

• Verified date: March 2023
• Source: Heart and Diabetes Center North-Rhine Westfalia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: May 15, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure

Intervention

Procedure:
• Atrial fibrillation ablation
Catheter ablation

Locations

Country	Name	City	State
Germany	Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum	Bad Oeynhausen

Sponsors (1)

Lead Sponsor	Collaborator
Heart and Diabetes Center North-Rhine Westfalia

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality or transplantation	composite of all-cause mortality, worsening of HF requiring a high urgent transplantation or implantation of a ventricular assist device	24 months