UPCC 03024 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) (ACC-RELEVANT STUDY) (RADIATE-VT)
Comparing Cardiac Radioablation and Repeat Catheter Ablation for Ventricular Tachycardia
Brief description of study
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Tachycardia, Ventricular
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Age: 18 years or above
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Gender: All
Inclusion 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:
- ≥3 episodes of monomorphic VT treated with anti-tachycardia pacing (ATP) at least one of which is symptomatic
- ≥1 appropriate ICD shock
- ≥3 episodes of sustained monomorphic VT within 24 hours treated with ICD shock or ATP
- sustained monomorphic VT below detection rate of ICD documented by ECG, and
- 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.
Exclusion Criteria:
- 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 preclude safe delivery of CRA.
- 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.
This study investigates the safety and effectiveness of cardiac radioablation compared to repeat catheter ablation for patients with high-risk refractory ventricular tachycardia (VT). This study focuses on patients who have experienced VT recurrence after a previous catheter ablation and are eligible for another ablation procedure.
Participants in the study will be randomly assigned to one of two study arms: cardiac radioablation or repeat catheter ablation. Cardiac radioablation is a procedure that uses radiation to treat the heart tissue causing VT. Repeat catheter ablation involves using a catheter to destroy the heart tissue responsible for the abnormal rhythm. The study will monitor the safety and effectiveness of these procedures for treating VT.
- Who can participate: Adults aged 18 and older with high-risk refractory ventricular tachycardia who have previously undergone catheter ablation for VT and have a left ventricular ejection fraction of 49% or less may participate. Participants must also have an implantable cardioverter-defibrillator (ICD) and have failed or be intolerant to amiodarone therapy.
- Study details: Participants will undergo either cardiac radioablation or repeat catheter ablation. Cardiac radioablation uses targeted radiation, while catheter ablation uses a catheter to treat the heart tissue causing VT.
Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.
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