Cohort Study - SBRT for VT Radioablation

Launched by JOHN SAPP · Nov 11, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with ventricular tachycardia (VT), a serious heart condition that can lead to sudden death. The trial is exploring the use of a non-invasive technique called stereotactic body radiotherapy (SBRT), which delivers targeted radiation to the areas of the heart that contribute to VT. This method is aimed at helping people who have not found relief from traditional treatments like medications or catheter ablation. By focusing on the scar tissue in the heart, the hope is to reduce or eliminate episodes of VT, improving patients' quality of life.

To be eligible for the trial, participants must have a specific type of heart disease and a history of VT that has not responded to previous treatments. Key criteria include having documented episodes of VT despite prior therapies or being unable to undergo catheter ablation. Participants can expect close monitoring throughout the study, and their experiences will contribute to understanding how effective this new treatment can be. It’s important to know that this trial is currently recruiting and is open to all genders.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Structural heart disease: ischemic or non-ischemic cardiomyopathy diagnosed with cardiac imaging demonstrating either segmental myocardial dysfunction, or presence of scar, AND
• • One of the following monomorphic VT events despite prior attempted catheter ablation (or contraindication for ablation), AND despite treatment with a class III antiarrhythmic drug (contraindicated, ineffective or not tolerated): A: Documented sustained monomorphic VT terminated by pharmacologic means, DC cardioversion or manual ICD Therapy. B: ≥3 episodes of monomorphic VT treated with antitachycardia pacing (ATP), at least one of which was symptomatic C: ≥ 5 episodes of monomorphic VT treated with antitachycardia pacing (ATP) regardless of symptoms D: ≥1 appropriate ICD shocks, E: ≥3 monomorphic VT episodes within 24 hours \*\* VT events must be confirmed by ECG/monitor or ICD download.
• Exclusion Criteria:
• • Unable or unwilling to provide informed consent
• • Have received prior radiotherapy to the likely treatment field
• • Inotrope-dependent heart failure or an anticipated life-expectancy of \< 1 year in the absence of VT
• • Presenting arrhythmia: polymorphic VT or ventricular fibrillation (VF)
• • Pregnancy
• • Active ischemia (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on ECG) or another reversible cause of VT (e.g. drug-induced arrhythmia), had recent acute coronary syndrome within 30 days thought to be due to acute coronary arterial thrombosis, or have CCS functional class IV angina. Note that biomarker level elevation alone after ventricular arrhythmias does not denote acute coronary syndrome or active ischemia.