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Completed

NCT Number: NCT04612140

STereotactic Ablative Radiosurgery of Recurrent Ventricular Tachycardia in Structural Heart Disease

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

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Key information

Conditions

Ventricular Tachycardia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Podlesí, Třinec, Moravian-Silesian Region, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

radiosurgery

Procedure

The study subjects randomized in this study arm will undergo a radiosurgery procedure.

Repeated catheter ablation

Procedure

The study subjects randomized in this study arm will undergo repeated catheter ablation.

Primary outcomes

  1. Recurrence of sustained VT after 3-month blanking period

    Time frame: 3 months

    Recurrence of sustained VT after 3-month blanking period will be assessed.

Secondary outcomes

  1. VT burden according to implantable device

    Time frame: 3 months

    Number of sustained VT burden in three 3-month intervals after radiosurgery will be assessed.

  2. Non-inducibility of VT at 6 months

    Time frame: 6 months

    TRUE/FALSE - Pacing protocol will be using 2 basic cycle length drives (600 and 400 ms) and 1-3 extrastimuli with coupling intervals decremented by 10 ms up to the refractoriness or 200 ms.

  3. Recurrence of sustained VT excluding antitachycardia-pacing (ATP)-treated episodes

    Time frame: 24 months

    Recurrence of sustained VT excluding ATP-treated episodes will be assessed.

  4. Electric storm recurrence

    Time frame: 24 months

    The recurrence of electric storm will be observed.

  5. Cardiovascular hospitalization

    Time frame: 24 months

    The number of hospitalisations due to cardiovascular indications will be observed.

  6. All-cause death

    Time frame: 24 months

    The all-cause death will be observed.

  7. Change in quality of life: EQ-5D

    Time frame: 24 months

    Change in quality of life will be observed using the standardised EQ-5D (5-dimension) questionnaire. EQ-5D is a standardised instrument in the form of a questionnaire developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The quality of life is assessed in five dimensions, with three levels in each dimension. The higher score the patient achieves, the better the quality of life.

  8. Change in echocardiographic indices

    Time frame: 24 months

    Left vetricle ejection fraction (%) will be observed.

  9. Rate of major procedure-related complications (control arm)

    Time frame: 24 months

    The rate of major procedure-related complications will be observed among the study subjects enrolled to the control arm of the study, according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0).

  10. Rate of acute post-radiation complications (intervention arm)

    Time frame: 24 months

    The rate of acute post-radiation complications will be observed among the study subjects enrolled to the intervention arm of the study, according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0)

  11. Extent of scar

    Time frame: 6 months

    The extent of scar will be assessed 6 months after radiosurgery, based on invasive electroanatomical mapping.

  12. Rate of late radiation-induced events

    Time frame: 24 months

    The rate of late radiation-induced events will be assessed according to CTCAE 5.0 in each cohort of isodose line level, specifically, rate of radiation myocarditis, pericarditis, and pneumonitis.

  13. Radiation dose

    Time frame: 24 months

    The radiation dose will be observed for each interventional procedure, CT imaging and radiosurgery, together with the cumulative dose.

  14. Need of antiemetic drugs

    Time frame: 24 months

    The need of antiemetic drugs will be assessed in all study subjects.

  15. Dynamics of serum troponin level

    Time frame: 24 months

    The dynamics of serum troponin level will be observed in all study subjects.

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Collaborators

  • Hospital Podlesi
  • Institute for Clinical and Experimental Medicine

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Nov 2, 2020
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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