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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
380
Subjects randomized to CRA will be treated with the Varian CRA system according to a uniform CRA protocol. A dose of 25 Gy in a single fraction is prescribed to the planning target volume (PTV), and delivered using a stereotactic body radiotherapy (SBRT) technique.
Subjects randomized to the CA arm will be treated according to a uniform CA protocol.
Cedars-Sinai Medical Center
Los Angeles, California, United States
RECRUITINGHartford Hospital
Hartford, Connecticut, United States
RECRUITINGBrigham & Women's Hospital
Boston, Massachusetts, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITINGWashington University
St Louis, Missouri, United States
RECRUITINGThe Ohio State University
Columbus, Ohio, United States
RECRUITINGUniversity of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGUniversity of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
RECRUITINGMedical University of South Carolina
Charleston, South Carolina, United States
RECRUITINGVanderbilt University Medical Center
Nashville, Tennessee, United States
RECRUITINGCo-primary safety endpoint: freedom from treatment-attributed (i.e., probably or definitely related) serious adverse events (SAEs)
Freedom from treatment-attributed (i.e., probably or definitely related) serious adverse events (SAEs), evaluated from treatment through 12 months post-treatment.
Time frame: Treatment through 12 months post-treatment
Co-primary efficacy endpoint: Freedom from death, and appropriate ICD shock, and VT storm.
Freedom from death, and appropriate ICD shock, and VT storm, where 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.
Time frame: 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
Change in quality of life at 6 weeks post treatment:
Change in quality of life at 6 weeks post treatment measured by the Short Form Health Survey 36 (SF-36) Health Change Question. This item asks the subject to rate their health in general compared to one year ago in a 5-point scale of 1 (much better), 2 (somewhat better), 3 (about the same), 4 (somewhat worse), 5 (much worse).
Time frame: From baseline through 6 weeks post treatment
VT burden reduction
VT burden reduction measured as a ≥75% reduction in appropriate ICD therapies (ATP, shock), comparing a 6-month period before randomization and a 6-month period starting after a 30-day period immediately post-randomization.
Time frame: From 6 months before randomization through to a 6 month period starting after a 30-day period immediately post-randomization
Change in quality of life (Social Functioning) at 6 weeks post treatment
Change in quality of life (Social Functioning) measured by the Short Form Health Survey 36 (SF-36) Social Functioning item (social activities in past 4 weeks). This item asks the subject to rate how much of the time their physical health or emotional problems interfered with their social activities in the past 4 weeks in a 5-point scale of 1 (All of the time), 2 (Most of the time), 3 (Some of the time), 4 (A little bit of the time), 5 (None of the time).
Time frame: From baseline through 6 weeks post treatment
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