Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evalua… (NCT05765175) | Clinical Trial Compass
RecruitingNot Applicable
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
United States380 participantsStarted 2023-04-21
Plain-language summary
RADIATE-VT is a pivotal, multicenter, randomized trial comparing safety and efficacy between cardiac radioablation (CRA) using the Varian CRA System and repeat catheter ablation (CA), for patients with high-risk refractory ventricular tachycardia (VT) who have experienced VT recurrence after CA and are candidates for additional CA.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. High-risk refractory VT, defined as:
✓. Ischemic and/or nonischemic cardiomyopathy, and
✓. Recurrent sustained monomorphic VT, defined as at least one of the following below, documented by ICD interrogation or ECG in the prior 6 months, and having occurred after the last VT ablation:
✓. Left ventricular ejection fraction (LVEF) ≤49% and
✓. Previously underwent at least one standard of care CA for VT.
✓. Presence of a clinical indication for a repeat CA procedure for scar-mediated VT in the judgement of the treating investigator.
✓. Has failed amiodarone therapy or is intolerant to amiodarone:
✓. Deemed to be medically and technically a candidate for further CA by the electrophysiologist investigator.
Exclusion criteria
✕. Contraindication to a CA procedure for VT (e.g., presence of mobile LV thrombus, active systemic infection, active ischemic or other reversible causes of VT).
✕. Patients with expected, right ventricular scar only.
✕. Any prior radiation to the thorax region of the body.
✕. Known medical conditions associated with higher risk of radiotherapy complications in the judgement of the radiation oncologist (i.e., active connective tissue disorders, interstitial lung disease, etc.) that would preclude safe delivery of CRA.
What they're measuring
1
Co-primary safety endpoint: freedom from treatment-attributed (i.e., probably or definitely related) serious adverse events (SAEs)
Timeframe: Treatment through 12 months post-treatment
2
Co-primary efficacy endpoint: Freedom from death, and appropriate ICD shock, and VT storm.
Timeframe: Death will be counted from randomization through 12 months, and shock and storm will be counted starting after a 30-day period immediately post-randomization and continuing through 12 months post randomization