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STereotactic Ablative Radiosurgery of Recurrent Ventricular Tachycardia in Structural Heart Disease | Clinical Trials | Clareo Health

COMPLETEDNA

STereotactic Ablative Radiosurgery of Recurrent Ventricular Tachycardia in Structural Heart Disease

NCT04612140•University Hospital Ostrava

View on ClinicalTrials.gov

Summary

A multicentre trial on clinical effects of radiosurgical ablation of ventricular tachycardia (VT).

Detailed Description

Patients with previously failed conventional RF catheter ablation will be randomized to radiosurgery (active treatment group) or repeated catheter ablation (control treatment group). Details on inclusion and exclusion criteria are provided below. Randomization Eligible patients will be assigned to 2 treatment arms - radiosurgery (active arm) or repeated catheter ablation (control arm) in 1:1 fashion by covariate-adaptive randomization algorithm considering age, gender, etiology of structural heart disease (SHD), left ventricular (LV) ejection fraction, and serum B-type natriuretic peptide (NT-proBNP) level.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients with structural heart disease (SHD) of any etiology (ischemic, non-ischemic, congenital corrected or uncorrected)
•2. Implanted implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D)
•3. Prior ≥1 catheter ablation procedure for VT due to SHD of them the last one performed in the expert center and employed:
•3.1 all meaningful mapping/ablation approaches (endocardial/epicardial access to left / right ventricular substrate as possible or appropriate) 3.2 precise electroanatomical mapping of the arrhythmogenic substrate in anticipation of future radiosurgery 3.3 additional mapping of structures used for precise image integration (aortic arch, left main ostium, right ventricular endocardial surface)
•4. VT recurrence after the last catheter ablation fulfilling all criteria as follows:
•4.1 clinically relevant and requiring further intervention 4.2 compatible with the previously characterized arrhythmogenic substrate 4.3 occurred on stable antiarrhythmic medication (mostly amiodarone) unless contraindicated 4.4 reversible cause excluded
•5. Signed an Institutional Review Board (IRB)-approved written informed consent

Exclusion Criteria

•1. Age \< 20 years
•2. Acute coronary syndrome or recent percutaneous coronary intervention or cardiac surgery (\< 3 months)
•3. Primary electrical disease (channelopathy)
•4. Pregnancy or breastfeeding
•5. Chronic heart failure with New York Heart Association (NYHA) Class IV
•6. Serious comorbidities with presumed life expectancy less than one year
•7. Significant peripheral artery disease precluding retrograde aortic mapping

Locations (2)

Hospital Podlesí

Třinec, Moravian-Silesian Region, Czechia

Institute for Clinical and Experimental Medicine

Prague, Czechia

Key Dates

Start Date

October 1, 2020

Primary Completion Date

June 30, 2024

Completion Date

June 30, 2024

Last Updated

June 4, 2025

Enrollment

ACTUAL participants

Conditions

Ventricular Tachycardia

Interventions

Radiosurgery

PROCEDURE

Repeated catheter ablation

PROCEDURE

Trial in Arrhythmia Radioablation for Ventricular Tachycardia: Single Fraction vs Three Fractions

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Ventricular Tachycardia

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RECRUITINGPHASE2

Safety, Tolerability, and Exploratory Efficacy of AGP100 in Patients With Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)

NCT07263139

Catecholaminergic Polymorphic Ventricular Tachycardia

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RECRUITING

Ventricular Arrhythmias in Patients Undergoing Mitral Valve Surgery

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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STereotactic Ablative Radiosurgery of Recurrent Ventricular Tachycardia in Structural Heart Disease

Inclusion Criteria

Exclusion Criteria

Trial in Arrhythmia Radioablation for Ventricular Tachycardia: Single Fraction vs Three Fractions

Safety, Tolerability, and Exploratory Efficacy of AGP100 in Patients With Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)

Ventricular Arrhythmias in Patients Undergoing Mitral Valve Surgery

Evaluation of Exercise Testing and Physical Activity in Children and Adolescents Living With Inherited Arrhythmias

Venous Ethanol for Ventricular Tachycardia

International Multicenter Project Comparing Radiofrequency Ablation Versus Implantable Defibrillator After Well-tolerated Ventricular Tachycardia in Ischemic Heart Disease with Minimally Impaired Ejection Fraction