RECRUITING

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)

Conditions

Tachycardia, Ventricular Cardiac radioablation Ventricular tachycardia Catheter ablation Refractory ventricular tachycardia High risk SBRT

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia

Quick Facts

Study Start:2023-04-21

Study Completion:2030-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05765175

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. High-risk refractory VT, defined as: 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: 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.	1. 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). 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.

Inclusion Criteria

Exclusion Criteria

1. High-risk refractory VT, defined as:
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:
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.

1. 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).
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.

Contacts and Locations

Study Contact

Claire McCann, PhD

CONTACT

437.240.4531

claire.mccann@varian.com

David J Harrington

CONTACT

+1 (434) 2422995

david.harrington@varian.com

Study Locations (Sites)

Cedars-Sinai Medical Center

Los Angeles, California, 90048

United States

Hartford Hospital

Hartford, Connecticut, 06102

United States

Brigham & Women's Hospital

Boston, Massachusetts, 02115

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

Washington University

Saint Louis, Missouri, 63110

United States

The Ohio State University

Columbus, Ohio, 43210

United States

Collaborators and Investigators

Sponsor: Varian, a Siemens Healthineers Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-21

Study Completion Date2030-05

Study Record Updates

Study Start Date2023-04-21

Study Completion Date2030-05

Terms related to this study

Keywords Provided by Researchers

Cardiac radioablation
Ventricular tachycardia
Catheter ablation
Refractory ventricular tachycardia
High risk
SBRT

Additional Relevant MeSH Terms

Tachycardia, Ventricular