Status:
WITHDRAWN
Stereotactic Non-invasive Ablation of Ventricular Tachycardia
Lead Sponsor:
University Hospital Ostrava
Collaborating Sponsors:
Institute for Clinical and Experimental Medicine
Hospital Podlesi
Conditions:
Ventricular Tachycardia
Eligibility:
All Genders
30+ years
Phase:
NA
Brief Summary
STereotactic Ablative Radiosurgery of recurrent Ventricular Tachycardia in structural heart disease (STAR-VT).
Detailed Description
The goal of this project is to evaluate feasibility and safety/toxicity of elimination of ventricular tachycardia (VT) associated with structural heart disease by noninvasive strategy, stereotactic ra...
Eligibility Criteria
Inclusion
- Patients with structural heart disease (ischemic and non-ischemic cardiomyopathy, previous surgery for congenital heart disease)
- Implanted ICD or CRT-D (cardiac resynchronization therapy defibrillator)
- Prior ≥1 catheter ablation procedure for monomorphic VT
- VT recurrence early (\<12 months) after the last ablation with at least 2 episodes of recurrent VT, including 1 episode while on amiodarone (if not contraindicated)
- Age ≥30 years
- Signed an IRB-approved (Institutional Review Board) written informed consent
Exclusion
- Acute myocardial infarction or recent percutaneous coronary intervention (PCI) or cardiac surgery (\<3 months)
- Primary electrical disease (channelopathy)
- Reversible cause of VT (e.g. drug-induced, intoxications, etc)
- Pregnancy or breastfeeding
- Chronic heart failure 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
- History of chest radiotherapy
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03819504
Start Date
August 1 2018
End Date
September 30 2020
Last Update
October 19 2020
Active Locations (3)
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1
Institute for Clinical and Experimental Medicine Prague
Prague, Central Bohemia, Czechia, 14021
2
University Hospital Ostrava
Ostrava-Poruba, Czech Republic, Czechia, 708 52
3
Hospital Podlesí
Třinec, Moravian-Silesian Region, Czechia, 73961