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

NCT04649801 | Completed

• 1 other identifier: HDZ_ER002_CS
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Failure; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

conventional

NO INTERVENTION

interventional

ACTIVE COMPARATOR

Procedure: Atrial fibrillation ablation

Interventions

Atrial fibrillation ablation PROCEDURE

Catheter ablation

interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Heart and Diabetes Center North-Rhine Westfalia: lead

Study Sites (1)

Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum

Bad Oeynhausen, 32545, Germany

Location

Related Publications (1)

• 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.

  PMID: 37634135 DERIVED

MeSH Terms

Conditions

Heart Failure; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: December 2, 2020
• Study Start: December 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: May 15, 2023
• Last Updated: May 17, 2023

Record last verified: 2023-03

Locations

DE (1)