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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
One of the following monomorphic VT events despite prior attempted catheter ablation (or contraindication for ablation), AND despite treatment with a class III antiarrhythmic drug (contraindicated, ineffective or not tolerated): A: Documented sustained monomorphic VT terminated by pharmacologic means, DC cardioversion or manual ICD Therapy. B: ≥3 episodes of monomorphic VT treated with antitachycardia pacing (ATP), at least one of which was symptomatic C: ≥ 5 episodes of monomorphic VT treated with antitachycardia pacing (ATP) regardless of symptoms D: ≥1 appropriate ICD shocks, E: ≥3 monomorphic VT episodes within 24 hours ** VT events must be confirmed by ECG/monitor or ICD download.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion,min of 7.5 months to max of 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
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I have had multiple specific heart rhythm problems despite treatment.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Comparative analysis of targeting methods assessed by volume of sparred healthy tissue
Comparative analysis of ventricular arrhythmia events
Secondary outcome measures
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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Imaging & SBRT Treatment for Ventricular TachycardiaExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

John SappLead Sponsor
5 Previous Clinical Trials
720 Total Patients Enrolled
Jean-Philippe Pignol, MD FRCPCStudy DirectorNova Scotia Health Authority
John Sapp, MD FRCPCPrincipal InvestigatorNova Scotia Health Authority
1 Previous Clinical Trials
4 Total Patients Enrolled

Media Library

Stereotactic Body Radiotherapy (SBRT) (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04162171 — N/A
Heart Attack Research Study Groups: Imaging & SBRT Treatment for Ventricular Tachycardia
Heart Attack Clinical Trial 2023: Stereotactic Body Radiotherapy (SBRT) Highlights & Side Effects. Trial Name: NCT04162171 — N/A
Stereotactic Body Radiotherapy (SBRT) (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04162171 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~0 spots leftby Jun 2024