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)
NCT ID: NCT05765175
Last Updated: 2025-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
380 participants
INTERVENTIONAL
2023-04-21
2030-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Repeat catheter ablation (CA)
Catheter Ablation (CA)
Subjects randomized to the CA arm will be treated according to a uniform CA protocol.
Varian Cardiac Radioablation (CRA)
Varian Cardiac Radioablation (CRA)
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.
Interventions
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Varian Cardiac Radioablation (CRA)
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.
Catheter Ablation (CA)
Subjects randomized to the CA arm will be treated according to a uniform CA protocol.
Eligibility Criteria
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Inclusion Criteria
1. Ischemic and/or nonischemic cardiomyopathy, and
2. 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:
A: ≥3 episodes of monomorphic VT treated with anti-tachycardia pacing (ATP) at least one of which is symptomatic
B: ≥1 appropriate ICD shock
C: ≥3 episodes of sustained monomorphic VT within 24 hours treated with ICD shock or ATP
D: sustained monomorphic VT below detection rate of ICD documented by ECG, and
3. Left ventricular ejection fraction (LVEF) ≤49% and
4. Previously underwent at least one standard of care CA for VT.
2. Presence of a clinical indication for a repeat CA procedure for scar-mediated VT in the judgement of the treating investigator.
3. Has failed amiodarone therapy or is intolerant to amiodarone:
* Failed amiodarone therapy is defined as: appropriate ICD therapy or sustained monomorphic VT having occurred while the patient was taking amiodarone (minimum cumulative dose of 10 g).
* Intolerant to amiodarone is defined as: previously tried or taken amiodarone but stopped due to medication related side effects or toxicities.
4. Deemed to be medically and technically a candidate for further CA by the electrophysiologist investigator.
5. Presence of an ICD.
6. At least 18 years of age (or meets local age of majority).
7. Ability to understand and willingness to sign an IRB approved written informed consent document.
Exclusion Criteria
2. Patients with expected, right ventricular scar only.
3. Any prior radiation to the thorax region of the body.
4. 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.
5. Current use of inotropes.
6. Presence of a left-ventricular assist device (LVAD).
7. Scheduled for LVAD or heart transplant procedures.
8. Presence of a systemic illness likely to limit survival to \< 1 year.
9. VT ablation procedure performed within the prior 2 weeks.
10. Polymorphic VT or ventricular fibrillation (VF) as the primary clinical heart rhythm, as indicated by 12-lead ECG and/or ICD interrogation.
11. \>3 distinct clinical monomorphic VT morphologies on ICD interrogation since the prior CA, or \>5 induced monomorphic VT morphologies during NIPS testing.
12. Incessant VT that is hemodynamically unstable.
13. Bundle branch reentry (BBR) VT.
14. Pregnant and/or breastfeeding. (Patient denial is sufficient for enrollment).
15. Patients of childbearing potential who:
* are not on a medically effective means of birth control at the time of screening or do not start a medically effective means of birth control prior to randomization; or
* do not agree to continue medically effective means of birth control until they have completed their assigned therapy; or
* do not agree to be on a medically effective means of birth control if they are treated with CRA after their index CA procedure.
16. Patients enrolled in another clinical study the investigator believes to be in conflict with this clinical investigation.
17. Patients enrolled or planned to be enrolled in another cardiac radioablation clinical study or registry.
18. Patients with any other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in this clinical investigation.
18 Years
ALL
No
Sponsors
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Varian, a Siemens Healthineers Company
INDUSTRY
Responsible Party
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Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
The Ohio State University
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Study Team Heart Rhythm Services
Role: backup
Role: primary
Other Identifiers
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VAR-2022-01
Identifier Type: -
Identifier Source: org_study_id
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