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)
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Varian, a Siemens Healthineers Company
- Study ID
- NCT05765175
- Status
- Recruiting
Conditions
- Tachycardia, Ventricular
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Varian Cardiac Radioablation (CRA) — DEVICESubjects 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.
- Catheter Ablation (CA) — PROCEDURESubjects randomized to the CA arm will be treated according to a uniform CA protocol.
Study Details
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.
Key Dates
- Start date
- Apr 21, 2023
- Status verified
- Apr 2026
- Primary completion
- May 31, 2026
- Completion
- May 31, 2030
Study Design
- Enrollment
- 380 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Repeat catheter ablation (CA)
- Experimental: Varian Cardiac Radioablation (CRA)
Primary Outcome Measure
Co-primary safety endpoint: freedom from treatment-attributed (i.e., probably or definitely related) serious adverse events (SAEs) [ Time Frame: Treatment through 12 months post-treatment ]
Central Contacts
- Claire McCann, PhD437.240.4531
- David J Harrington+1 (434) 2422995
Locations (11)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | Ashkan Ehdaie, MD (PRINCIPAL_INVESTIGATOR) |
| Hartford Hospital | Hartford | Connecticut | 06102 | Aneesh Tolat, MD (PRINCIPAL_INVESTIGATOR) |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | Usha Tedrow, MD (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic | Rochester | Minnesota | 55905 | Study Team Heart Rhythm Services 5072550774 Kenneth Merrell, MD (PRINCIPAL_INVESTIGATOR) Konstantinos Siontis, MD (SUB_INVESTIGATOR) |
| University of Missouri | Columbia | Missouri | 65211 | Rahul Jain, MD (PRINCIPAL_INVESTIGATOR) |
| Washington University | St Louis | Missouri | 63110 | Kaitlin Moore Daniel Cooper, MD (PRINCIPAL_INVESTIGATOR) |
| The Ohio State University | Columbus | Ohio | 43210 | Jeremy Brownstein, MD (PRINCIPAL_INVESTIGATOR) |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | Keith Cengel, MD (PRINCIPAL_INVESTIGATOR) |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15260 | Krishna Kancharla, MD (PRINCIPAL_INVESTIGATOR) |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | 843-792-5998 Jeffrey Winterfield, MD (PRINCIPAL_INVESTIGATOR) |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | William G Stevenson, MD (PRINCIPAL_INVESTIGATOR) |