Version: Protocol Number VAR-2022-01, Short title: RADIATE-VT
Research type
Research Study
Full title
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)
IRAS ID
338385
Contact name
Ahmad Shahreen
Contact email
Sponsor organisation
Varian Medical Systems, a Siemens Healthineers Company
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 6 months, 1 days
Research summary
The purpose of this study is to test whether an experimental medical device is safe and effective in performing an experimental treatment – called cardiac radioablation in patients who have had a previous catheter ablation (CA) procedure for Ventricular Tachycardia (VT) and whose VT has come back for which a repeat CA procedure is an option for treatment. This study focuses on patients with high-risk refractory VT. Refractory VT means that the VT is not well controlled with medication or CA.
Cardiac radioablation will be performed in the hospital’s radiation oncology department using a device (machine) called a linear accelerator, which delivers multiple highly focused beams of radiation to treat the area of the heart that is judged by your doctors to be the source of the VT. The linear accelerator is a medical device used to deliver radiation treatments. This type of machine has been in worldwide use for over 50 years and is most commonly used for the treatment of different cancers. Radiation treatments are provided as an outpatient procedure (patients typically go home right after radiation treatment is delivered).
The Sponsor of this research study has developed an experimental medical device specifically to be used for cardiac radioablation with an existing linear accelerator. This new medical device includes computer software that helps study doctors to identify the part of the heart that is the source of VT. This information is then used to plan the radiation treatment and then deliver it with an existing linear accelerator.
Participants in this research study will be treated either with cardiac radioablation delivered in one treatment session, in the hospital’s radiation oncology department, using the experimental medical device, or with a routine CA - a standard of care treatment for patients with recurrent VT - performed in the hospital’s cardiac electrophysiology department.
About 380 participants from multiple hospitals around the world are expected to be enrolled in the study (approximately 190 participants will be treated with cardiac radioablation and approximately 190 with CA).Each participant is expected to participate in study visits for up to approximately 5 years from the beginning to the end of the study.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
24/EE/0092
Date of REC Opinion
13 Jun 2024
REC opinion
Further Information Favourable Opinion