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

NCT ID: NCT04649801

Last Updated: 2023-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2023-05-15

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.

Conditions

Heart Failure; Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

conventional

Group Type: NO_INTERVENTION

No interventions assigned to this group

interventional

Group Type: ACTIVE_COMPARATOR

Atrial fibrillation ablation

Intervention Type: PROCEDURE

Catheter ablation

Interventions

Atrial fibrillation ablation

Catheter ablation

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Heart and Diabetes Center North-Rhine Westfalia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum

Bad Oeynhausen, , Germany

Countries

Germany

References

Sohns C, Fox H, Marrouche NF, Crijns HJGM, Costard-Jaeckle A, Bergau L, Hindricks G, Dagres N, Sossalla S, Schramm R, Fink T, El Hamriti M, Moersdorf M, Sciacca V, Konietschke F, Rudolph V, Gummert J, Tijssen JGP, Sommer P; CASTLE HTx Investigators. Catheter Ablation in End-Stage Heart Failure with Atrial Fibrillation. N Engl J Med. 2023 Oct 12;389(15):1380-1389. doi: 10.1056/NEJMoa2306037. Epub 2023 Aug 27.

Reference Type: DERIVED

PMID: 37634135 (View on PubMed)

Other Identifiers

HDZ_ER002_CS

Identifier Type: -

Identifier Source: org_study_id