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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