CompletedNo phase
STereotactic Ablative Radiosurgery of Recurrent Ventricular Tachycardia in Structural Heart Disease
Key facts
- Who runs it
- University Hospital Ostrava
- Where
- Czechia2 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 22 people enrolled
- Started
- 1 Oct 2020
- Ended
- 30 Jun 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Radiosurgery
- Repeated catheter ablation
- Record updated
- 4 June 2025
Who can take part
- Age
- 20 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- Patients with structural heart disease (SHD) of any etiology (ischemic, non-ischemic, congenital corrected or uncorrected)
- Implanted implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D)
- 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)
- 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
- Signed an Institutional Review Board (IRB)-approved written informed consent
Who cannot take part
- Acute coronary syndrome or recent percutaneous coronary intervention or cardiac surgery (< 3 months)
- Primary electrical disease (channelopathy)
- Chronic heart failure with New York Heart Association (NYHA) Class IV
- Significant peripheral artery disease precluding retrograde aortic mapping
- Age < 20 years
- Pregnancy or breastfeeding
- Serious comorbidities with presumed life expectancy less than one year
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
A multicentre trial on clinical effects of radiosurgical ablation of ventricular tachycardia (VT).
The 2 groups in the trial
- RadiosurgeryTreatment being tested
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 SHD, LV ejection fraction, and serum NT-proBNP level.
- Repeated catheter ablationExisting treatment, for comparison
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 SHD, LV ejection fraction, and serum NT-proBNP level.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Publications
- Record updated
- 4 June 2025