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Preventive Catheter Ablation for Ventricular arrhythmiaS in Patients With End-sTage Heart faiLure

NCT ID: NCT06556485

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-13

Study Completion Date

2027-01-01

Brief Summary

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CASTLE-VT is a randomized evaluation of prophylactic ablative treatment of arrhythmogenic ventricular scar in patients referred for HTx evaluation and diagnosed with ICM. Ablation will be performed with the use of a substrate-based approach in which the myocardial scar is mapped and ablated while the heart remains predominantly in sinus rhythm. The primary end point is the composite of all-cause mortality, worsening of HF requiring prioritized transplantation or LVAD implantation. The main secondary study end points are all-cause mortality, cardiovascular mortality, incidence of implantable cardioverter-defibrillator (ICD) therapy, hospitalizations, Quality of life, time to first ICD therapy, number of device-detected ventricular tachycardia/ventricular fibrillation episodes, LV function, and exercise tolerance. CASTLE-VT will randomize 160 patients with a follow up period of 2 years.

Detailed Description

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Conditions

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Heart Failure Arrhythmia, Ventricular Cardiomyopathy Ischemic Catheter Ablation Heart Transplantation Left Ventricular Assist Device

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ablation group

Primary prophylactic ablation

Group Type ACTIVE_COMPARATOR

Catheter ablation

Intervention Type PROCEDURE

Preventive ablation therapy

Control group

Optimal medical therapy

Group Type ACTIVE_COMPARATOR

Medical therapy

Intervention Type DRUG

Optimal medical therapy

Interventions

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Catheter ablation

Preventive ablation therapy

Intervention Type PROCEDURE

Medical therapy

Optimal medical therapy

Intervention Type DRUG

Other Intervention Names

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Ablation Medical

Eligibility Criteria

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Inclusion Criteria

1. Ischemic cardiomyopathy with left ventricular ejection fraction ≤ 35% (measured in the last 6 weeks prior to enrollment)
2. Eligible for heart transplantation due to end-stage heart failure
3. NYHA class ≥ III
4. Impaired functional capacity or inability to exercise
5. Indication for ICD therapy due to primary prevention
6. Implanted ICD or ICD implantation within 3 months after randomization
7. The patient is willing and able to comply with the protocol and has provided written informed consent
8. Age ≥ 18 years

Exclusion Criteria

1. Previous catheter ablation for ventricular arrhythmias
2. Previous appropriate ICD-therapy for ventricular arrhythmias
3. Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 4 weeks prior to enrollment
4. Untreated hypothyroidism or hyperthyroidism
5. Woman currently pregnant, breastfeeding, or not using reliable contraceptive measures during fertility age
6. Mental or physical inability to participate in the study
7. Listed as "high urgent" for heart transplantation
8. Cardiac assist device implanted
9. Planned cardiovascular intervention
10. Life expectancy ≤ 12 month
11. Uncontrolled hypertension
12. Requirement for dialysis due to end-stage renal failure
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heart and Diabetes Center North-Rhine Westfalia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinic for Electrophysiology, Herz- und Diabeteszentrum NRW

Bad Oeynhausen, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Christian Sohns, MD

Role: CONTACT

[email protected]
49 5731 971327

Astrid Kleemeyer

Role: CONTACT

[email protected]
49 5731 971258

Facility Contacts

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Astrid Kleemeyer

Role: primary

[email protected]
0495731971258

Other Identifiers

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HDZ-ER_004_CS

Identifier Type: -

Identifier Source: org_study_id