Using radiation therapy to treat ventricular tachycardia

A Phase I/II Study of Cardiac Radioablation for Refractory Ventricular Tachycardia

This study is testing whether lower doses of radiation therapy can help people with hard-to-treat ventricular tachycardia have fewer episodes of this fast heart rhythm.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: William Beaumont Hospitals (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Royal Oak, Michigan)
• Trial ID: NCT06593418 on ClinicalTrials.gov

What this trial studies

This interventional study aims to determine the minimum radiation dose required to effectively reduce episodes of refractory ventricular tachycardia (VT) by half. It will utilize Delayed Enhancement Cardiac MRI (DE-CMR) to define target volumes for treatment. The study will compare lower doses of radiation therapy, starting at 15 Gy, to the standard dose of 25 Gy to assess their effectiveness in changing the heart's electrical conduction and reducing VT episodes. Participants will be identified by their cardiologists and must have a history of VT that is resistant to other treatments.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with a history of monomorphic VT and an automatic implanted cardiac defibrillator who have not responded to previous treatments.

Not a fit: Patients with class IV heart failure or those who have received prior radiation therapy to the chest may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a less invasive and more effective treatment option for patients suffering from refractory ventricular tachycardia.

How similar studies have performed: Previous studies have shown promise with cardiac radioablation, but this specific approach of testing lower radiation doses is novel.

Eligibility criteria

Inclusion Criteria:

* Participants must be 18 years or older.
* Automatic implanted cardiac defibrillator present.
* VT is monomorphic with at least two episodes of VT within an eight week (56 day) period as recorded by an AICD or heart failure related to VT or VT storm.
* Ejection fraction ≥20%.
* At least one previous cardiac ablation for VT.
* VT refractory despite antiarrhythmic medications.
* Likely to live for 12 months in the absence of VT.
* AICD in a position in the chest RT to be given without direct radiation.
* Woman of reproductive age must ensure that she won't become pregnant or breastfeed at the time of RT.
* The participant has no contraindications to a Cardiac MRI as per routine Cardiology practice.

Exclusion Criteria:

* Class IV heart failure
* Abandoned leads.
* Prior radiation therapy to the chest or upper abdomen.
* Interstitial lung disease.

Where this trial is running

Royal Oak, Michigan

• Corewell Health William Beaumont University Hospital — Royal Oak, Michigan, United States (Recruiting)

Study contacts

• Principal investigator: John Robertson, MD — Corewell Health William Beaumont University Hospital
• Study coordinator: John Roberston, MD

Conditions Ventricular Tachycardia; Myocardial Infarction