Completed

CASTLE-HTxCatheter Ablation for Atrial Fibrillation in Severe Left Ventricular Dysfunction

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Study Aim

This study aims to evaluate the effectiveness of catheter ablation as a treatment for atrial fibrillation in individuals with severe left ventricular dysfunction, with the primary outcome being a reduction in mortality or the need for heart transplantation.

What is being tested

Atrial fibrillation ablation

Procedure
Who is being recruted

Arrhythmias, Cardiac+4

+ Atrial Fibrillation

+ Cardiovascular Diseases

Over 18 Years
+25 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: December 2020
See protocol details

Summary

Principal SponsorHeart and Diabetes Center North-Rhine Westfalia
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2020

Actual date on which the first participant was enrolled.

This study focuses on a treatment called catheter ablation for atrial fibrillation (AF) in patients with severe heart failure who are eligible for a heart transplant. Atrial fibrillation is a type of irregular heartbeat that can make heart failure worse. The goal of the study is to see if this treatment can improve outcomes in these patients. The study is important because it could help find a better way to manage atrial fibrillation in patients with severe heart failure, potentially improving their quality of life and survival rates. During the study, participants will be randomly assigned to receive either the catheter ablation treatment or standard care. The catheter ablation procedure involves using a small tube (catheter) to apply energy to the areas of the heart causing the irregular heartbeat, which can help restore a normal heart rhythm. The study will measure the results by looking at whether participants experience a combination of any of the following: death from any cause, worsening of heart failure requiring a urgent transplantation or implantation of a heart pump, and improvement in quality of life. For participants who undergo a heart pump implantation or heart transplant, a small sample of heart tissue will be taken to study the effects of the catheter ablation on the heart muscle.

Official TitleCatheter Ablation for Atrial Fibrillation in patientS With End-sTage Heart Failure and Eligibility for Heart Transplantation (CASTLE-HTx)
NCT04649801
Principal SponsorHeart and Diabetes Center North-Rhine Westfalia
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

194 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arrhythmias, CardiacAtrial FibrillationCardiovascular DiseasesHeart DiseasesHeart FailurePathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

9 inclusion criteria required to participate
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.
Show More Criteria
16 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum

Bad Oeynhausen, GermanyOpen Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum in Google Maps
CompletedOne Study Center