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Procedure

Radiation Therapy for Ventricular Tachycardia

N/A
Waitlist Available
Led By John Robertson, MD
Research Sponsored by William Beaumont Hospitals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least one previous cardiac ablation for VT
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
Must not have
Class IV heart failure
Prior radiation therapy to the chest or upper abdomen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 56 days pre-treatment and 98 days post treatment (42 day blanking period plus 56 days)
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to find the lowest effective dose for treating a type of heart rhythm disorder called refractory ventricular tachycardia. They will also investigate the use of a specific imaging technique called

Who is the study for?
This trial is for adults who've had a heart attack and suffer from ventricular tachycardia (VT), which hasn't improved after at least one cardiac ablation. They must have an implanted defibrillator, not be pregnant or breastfeeding if of reproductive age, and should not have severe heart failure or prior chest radiation.
What is being tested?
The study tests the lowest effective dose of Stereotactic Body Radiation Therapy (SBRT) to treat VT that's resistant to other treatments. It also examines how well Delayed Enhancement Cardiac MRI helps in targeting the therapy area.
What are the potential side effects?
Potential side effects may include skin reactions where radiation is applied, fatigue, shortness of breath, chest pain or discomfort due to inflammation caused by radiation, and possible damage to nearby organs like the lungs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had a procedure to correct heart rhythm problems.
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I have had at least two episodes of a specific type of irregular heartbeat in the last 8 weeks.
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My heart condition hasn't improved with medication.
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I am 18 years old or older.
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My heart device is placed where it won't be affected by chest radiation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe heart failure.
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I have had radiation therapy to my chest or upper abdomen before.
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I have interstitial lung disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~56 days pre-treatment and 98 days post treatment (42 day blanking period plus 56 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 56 days pre-treatment and 98 days post treatment (42 day blanking period plus 56 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in number of ventricular tachycardia (VT) episodes from pre-cardiac radioablation to post-cardiac radioablation
Dose limiting toxicity
Secondary study objectives
Efficacy of ablation using target volume definition with Delayed Enhancement Cardiac MRI (DE-CMR)

Side effects data

From 2018 Phase 2 trial • 35 Patients • NCT01360593
21%
Anemia
18%
Neutropenia
15%
Hypoalbuminemia
15%
White blood cell decreased ( leukopenia)
15%
Diarrhea
12%
Liver Dysfunction
9%
Hand-Foot
3%
Bleeding
3%
Stroke
3%
Abdominal Infection
3%
Ileus
3%
Mucositis
3%
Edema
3%
Dermatitis
3%
Platelet count decreased ( Thrombocytopenia)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gem + Xeloda + SBRT

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Radiation Therapy at 25 Gy for Ventricular TachycardiaExperimental Treatment1 Intervention
Post myocardial infarction patients with refractory ventricular tachycardia requiring cardio ablation, treated with 25 Gy
Group II: Radiation Therapy at 20 Gy for Ventricular TachycardiaExperimental Treatment1 Intervention
Post myocardial infarction patients with refractory ventricular tachycardia requiring cardio ablation, treated with 20 Gy
Group III: Radiation Therapy at 15 Gy for Ventricular TachycardiaExperimental Treatment1 Intervention
Post myocardial infarction patients with refractory ventricular tachycardia requiring cardio ablation, treated with 15 Gy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy (SBRT)
2018
Completed Phase 2
~950

Find a Location

Who is running the clinical trial?

William Beaumont HospitalsLead Sponsor
151 Previous Clinical Trials
112,586 Total Patients Enrolled
John Robertson, MDPrincipal InvestigatorCorewell Health William Beaumont University Hospital
1 Previous Clinical Trials
462 Total Patients Enrolled
~16 spots leftby Aug 2026
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