Cohort Study - SBRT for VT Radioablation
- Conditions
- Myocardial InfarctionVentricular TachycardiaHeart Disease Structural Disorder
- Registration Number
- NCT04162171
- Lead Sponsor
- John Sapp
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria:<br><br> - Structural heart disease: ischemic or non-ischemic cardiomyopathy diagnosed with<br> cardiac imaging demonstrating either segmental myocardial dysfunction, or presence<br> of scar, AND<br><br> - One of the following monomorphic VT events despite prior attempted catheter ablation<br> (or contraindication for ablation), AND despite treatment with a class III<br> antiarrhythmic drug (contraindicated, ineffective or not tolerated): A: Documented<br> sustained monomorphic VT terminated by pharmacologic means, DC cardioversion or<br> manual ICD Therapy. B: =3 episodes of monomorphic VT treated with antitachycardia<br> pacing (ATP), at least one of which was symptomatic C: = 5 episodes of monomorphic<br> VT treated with antitachycardia pacing (ATP) regardless of symptoms D: =1<br> appropriate ICD shocks, E: =3 monomorphic VT episodes within 24 hours ** VT events<br> must be confirmed by ECG/monitor or ICD download.<br><br>Exclusion Criteria:<br><br> - Unable or unwilling to provide informed consent<br><br> - Have received prior radiotherapy to the likely treatment field<br><br> - Inotrope-dependent heart failure or an anticipated life-expectancy of < 1 year in<br> the absence of VT<br><br> - Presenting arrhythmia: polymorphic VT or ventricular fibrillation (VF)<br><br> - Pregnancy<br><br> - Active ischemia (acute thrombus diagnosed by coronary angiography, or dynamic ST<br> segment changes demonstrated on ECG) or another reversible cause of VT (e.g.<br> drug-induced arrhythmia), had recent acute coronary syndrome within 30 days thought<br> to be due to acute coronary arterial thrombosis, or have CCS functional class IV<br> angina. Note that biomarker level elevation alone after ventricular arrhythmias does<br> not denote acute coronary syndrome or active ischemia.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparative analysis of ventricular arrhythmia events;Comparative analysis of targeting methods assessed by volume of sparred healthy tissue
- Secondary Outcome Measures
Name Time Method Number of patients with procedural complications, including: all cause mortality, pericarditis, pneumonitis, heart failure hospitalization and extra-cardiac injury;Time to Recurrent Arrhythmia Outcomes;Ventricular arrhythmia Burden