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Compares treatment options for Tachycardia, Ventricular
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 (RADIATE-VT)
ClinicalTrials.gov ID: NCT05765175
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- High-risk refractory VT, defined as:
- Ischemic and/or nonischemic cardiomyopathy, and
- 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...
- Left ventricular ejection fraction (LVEF) ≤49% and
- Previously underwent at least one standard of care CA for VT.
You likely can't join if
- Contraindication to a CA procedure for VT (e.g., presence of mobile LV thrombus, active systemic infection, active ischemic or other reversible...
- Patients with expected, right ventricular scar only.
- Any prior radiation to the thorax region of the body.
- Known medical conditions associated with higher risk of radiotherapy complications in the judgement of the radiation oncologist (i.e., active...
- Current use of inotropes.
- Presence of a left-ventricular assist device (LVAD).
See the full eligibility criteria
- High-risk refractory VT, defined as:
- Ischemic and/or nonischemic cardiomyopathy, and
- 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...
- Left ventricular ejection fraction (LVEF) ≤49% and
- Previously underwent at least one standard of care CA for VT.
- Presence of a clinical indication for a repeat CA procedure for scar-mediated VT in the judgement of the treating investigator.
- 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.
- Deemed to be medically and technically a candidate for further CA by the electrophysiologist investigator.
- Presence of an ICD.
- At least 18 years of age (or meets local age of majority).
- Ability to understand and willingness to sign an IRB approved written informed consent document.
- 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).
- Patients with expected, right ventricular scar only.
- Any prior radiation to the thorax region of the body.
- 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...
- Current use of inotropes.
- Presence of a left-ventricular assist device (LVAD).
- Scheduled for LVAD or heart transplant procedures.
- Presence of a systemic illness likely to limit survival to \< 1 year.
- VT ablation procedure performed within the prior 2 weeks.
- Polymorphic VT or ventricular fibrillation (VF) as the primary clinical heart rhythm, as indicated by 12-lead ECG and/or ICD interrogation.
- \>3 distinct clinical monomorphic VT morphologies on ICD interrogation since the prior CA, or \>5 induced monomorphic VT morphologies during NIPS testing.
- Incessant VT that is hemodynamically unstable.
- Bundle branch reentry (BBR) VT.
- Pregnant and/or breastfeeding. (Patient denial is sufficient for enrollment).
- 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.
- Patients enrolled in another clinical study the investigator believes to be in conflict with this clinical investigation.
- Patients enrolled or planned to be enrolled in another cardiac radioablation clinical study or registry.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Hartford, Connecticut, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- Columbia, Missouri, United States
- St Louis, Missouri, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Charleston, South Carolina, United States
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Hartford, Connecticut, United States; Boston, Massachusetts, United States; Rochester, Minnesota, United States; Columbia, Missouri, United States; St Louis, Missouri, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.