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Radiation Therapy

SBRT for Ventricular Tachycardia

N/A

Recruiting

Led By John Sapp, MD FRCPC

Research Sponsored by John Sapp

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Structural heart disease: ischemic or non-ischemic cardiomyopathy diagnosed with cardiac imaging demonstrating either segmental myocardial dysfunction, or presence of scar

Must not have

Active ischemia (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on ECG) or another reversible cause of VT (e.g. drug-induced arrhythmia), had recent acute coronary syndrome within 30 days thought to be due to acute coronary arterial thrombosis, or have CCS functional class IV angina. Note that biomarker level elevation alone after ventricular arrhythmias does not denote acute coronary syndrome or active ischemia.

Inotrope-dependent heart failure or an anticipated life-expectancy of < 1 year in the absence of VT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion,min of 7.5 months to max of 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the use of SBRT to see if it can help people with VT that has not been helped by other treatments.

Who is the study for?

This trial is for people with heart conditions like a heart attack or ventricular tachycardia, who've tried other treatments without success. They must have had specific types of VT events despite medication and possibly catheter ablation. Pregnant individuals, those with life expectancy under one year (excluding VT), recent acute coronary syndrome, or prior radiotherapy in the treatment area cannot join.

What is being tested?

The study tests Stereotactic Body Radiotherapy (SBRT) as a non-invasive option to target and treat areas of the heart responsible for causing dangerous rapid heartbeats known as ventricular tachycardia (VT). It aims to provide an alternative when standard therapies like drugs or invasive procedures fail.

What are the potential side effects?

Potential side effects may include damage to nearby organs due to radiation exposure, skin reactions similar to sunburns, fatigue after treatment sessions, and rare cases of secondary cancers from long-term radiation effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have heart disease shown by imaging to affect heart muscle function or show scarring.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had a recent heart attack or severe chest pain due to heart issues.

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I have severe heart failure or am expected to live less than a year without treatment for VT.

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I have a type of irregular heartbeat known as polymorphic VT or VF.

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I have had radiation treatment in the area likely to be treated again.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion,min of 7.5 months to max of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion,min of 7.5 months to max of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion,min of 7.5 months to max of 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Comparative analysis of targeting methods assessed by volume of sparred healthy tissue

Comparative analysis of ventricular arrhythmia events

Secondary study objectives

Number of patients with procedural complications, including: all cause mortality, pericarditis, pneumonitis, heart failure hospitalization and extra-cardiac injury

Time to Recurrent Arrhythmia Outcomes

Ventricular arrhythmia Burden