Zapping the heart: could one radiation dose replace repeat surgery for lethal rhythms?
NCT ID NCT05765175
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new approach for people with a life-threatening fast heart rhythm called ventricular tachycardia (VT) that keeps coming back after standard treatment. It compares a single, targeted radiation dose (cardiac radioablation) to a repeat catheter ablation, which is a procedure that scars the heart tissue causing the problem. The trial will enroll 380 high-risk patients and measure safety and effectiveness over one year, including freedom from death, shocks from an implanted defibrillator, and severe rhythm storms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cardiac radioablation (a single high-dose radiation treatment) and catheter ablation (a standard procedure to destroy heart tissue causing abnormal rhythms)
- What this could lead to
- If it works, this could offer a less invasive, one-time treatment option for patients with dangerous heart rhythm problems who have not been helped by standard procedures.
- What could go wrong
- This is a pivotal trial but still experimental. Radiation to the heart carries risks like damage to nearby organs, and it may not control the heart rhythm as well as hoped. The study is also limited to high-risk patients who have already failed one ablation.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 380 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2023
- Expected to finish
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May 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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: 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: 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
11 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Brigham & Women's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
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Cedars-Sinai Medical Center
RECRUITINGLos Angeles, California, 90048, United States
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Hartford Hospital
RECRUITINGHartford, Connecticut, 06102, United States
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Mayo Clinic
RECRUITINGRochester, Minnesota, 55905, United States
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Medical University of South Carolina
RECRUITINGCharleston, South Carolina, 29425, United States
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The Ohio State University
RECRUITINGColumbus, Ohio, 43210, United States
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University of Missouri
RECRUITINGColumbia, Missouri, 65211, United States
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University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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University of Pittsburgh Medical Center
RECRUITINGPittsburgh, Pennsylvania, 15260, United States
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Vanderbilt University Medical Center
RECRUITINGNashville, Tennessee, 37232, United States
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Washington University
RECRUITINGSt Louis, Missouri, 63110, United States
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