Cardiac Radioablation for VT

NCT06593418 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 2024-069
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional study is to determine the minimum dose necessary for successful cardiac radioablation of refractory ventricular tachycardia (VT) and to study the utility of target volume definition using Delayed Enhancement Cardiac MRI (DE-CMR) .

Conditions

Ventricular Tachycardia; Myocardial Infarction

Outcome Measures

Primary Outcomes (2)

• Change in number of ventricular tachycardia (VT) episodes from pre-cardiac radioablation to post-cardiac radioablation

  Change in the number of episodes of VT over the 56 days before treatment versus over a consecutive 56 days post treatment (following the 6 week post-treatment blanking period). A negative number represents a reduction in episodes after treatment (improved function) and a positive number represents an increase in episodes after treatment (worsened function).

  56 days pre-treatment and 98 days post treatment (42 day blanking period plus 56 days)

• Dose limiting toxicity

  Number of participants who had dose limiting toxicity defined as any grade 3 toxicity requiring hospitalization or any grade 4-5 toxicity determined to be treatment-related.

  14 weeks

Secondary Outcomes (1)

• Efficacy of ablation using target volume definition with Delayed Enhancement Cardiac MRI (DE-CMR)

  56 days pre-treatment and 98 days post treatment (42 day blanking period plus 56 days)

Study Arms (3)

Radiation Therapy at 15 Gy for Ventricular Tachycardia

EXPERIMENTAL

Post myocardial infarction patients with refractory ventricular tachycardia requiring cardio ablation, treated with 15 Gy

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Radiation Therapy at 20 Gy for Ventricular Tachycardia

EXPERIMENTAL

Post myocardial infarction patients with refractory ventricular tachycardia requiring cardio ablation, treated with 20 Gy

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Radiation Therapy at 25 Gy for Ventricular Tachycardia

EXPERIMENTAL

Post myocardial infarction patients with refractory ventricular tachycardia requiring cardio ablation, treated with 25 Gy

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Interventions

Stereotactic Body Radiation Therapy (SBRT) RADIATION

Stereotactic body radiation therapy, which delivers precise, high-dose radiation non-invasively to generate thermal scarring to myocardial targets causing VT

Radiation Therapy at 15 Gy for Ventricular Tachycardia; Radiation Therapy at 20 Gy for Ventricular Tachycardia; Radiation Therapy at 25 Gy for Ventricular Tachycardia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Tachycardia, Ventricular; Myocardial Infarction

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Necrosis

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• John Robertson, MD

  Corewell Health William Beaumont University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Roberston, MD

CONTACT

248-551-7038; john.robertson@corewellhealth.org

Kristen Grant, RN

CONTACT

248-551-0439; kristen.grant@corewellhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director, Radiation Oncology

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)