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Cardiac Radioablation for VT

ConditionsVentricular TachycardiaMyocardial Infarction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCorewell Health East

About this trial

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) .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%.

Disqualifiers

Class IV heart failure

Abandoned leads.

Prior radiation therapy to the chest or upper abdomen.

Interstitial lung disease.

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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

Treatment groups

24 Participants
are divided into 3 treatment groups
Group A: Radiation Therapy at 15 Gy for Ventricular TachycardiaExperimental treatment 1 intervention
Group B: Radiation Therapy at 20 Gy for Ventricular TachycardiaExperimental treatment 1 intervention
Group C: Radiation Therapy at 25 Gy for Ventricular TachycardiaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
56 days pre-treatment and 98 days post treatment (42 day blanking period plus 56 days)
2

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.

Time frame
14 weeks

Secondary outcomes

1

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

Number of participants who had successful cardiac radioablation using target volume definition DE-CMR, defined as a 50% or higher reduction in the number of episodes of VT archived over the 56 days before treatment (obtained from their automatic internal cardiac defibrillator (AICD) device) versus over a consecutive 56 days after treatment starting after the 6-week post-treatment blanking period.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Corewell Health East

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: