Radiosurgery for treating recurrent ventricular tachycardia in patients with heart disease
STereotactic Ablative Radiosurgery of Recurrent Ventricular Tachycardia in Structural Heart Disease
This study is testing whether a new type of targeted radiation treatment can help people with heart disease who keep having heart rhythm problems after previous treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | University Hospital Ostrava Academic / other |
| Locations | 2 sites (Třinec, Moravian-Silesian Region and 1 other locations) |
| Trial ID | NCT04612140 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of stereotactic ablative radiosurgery in patients with recurrent ventricular tachycardia (VT) who have previously undergone failed catheter ablation. Participants will be randomly assigned to receive either radiosurgery or repeated catheter ablation, with the aim of evaluating the clinical outcomes of each approach. The study employs a covariate-adaptive randomization algorithm to ensure balanced treatment groups based on various patient characteristics. The trial is multicenter, involving multiple hospitals to enhance the diversity and applicability of the findings.
Who should consider this trial
Good fit: Ideal candidates include patients with structural heart disease who have experienced recurrent ventricular tachycardia after previous catheter ablation procedures.
Not a fit: Patients who have not undergone prior catheter ablation or those without structural heart disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients with recurrent VT who have not responded to conventional therapies.
How similar studies have performed: While the use of radiosurgery in this context is relatively novel, similar approaches in other conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Třinec, Moravian-Silesian Region and 1 other locations
- Hospital Podlesí — Třinec, Moravian-Silesian Region, Czechia (Recruiting)
- Institute for Clinical and Experimental Medicine — Praha, Czechia (Recruiting)
Study contacts
- Principal investigator: Jakub Cvek, Ass.Prof.,MD,Ing, PhD,MBA — University Hospital Ostrava
- Study coordinator: Petr Vávra, Ass.Prof.,MD,PhD
- Email: veda@fno.cz
- Phone: 0042059737
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.