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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
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 belowSelect...
I have heart disease shown by imaging to affect heart muscle function or show scarring.
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
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
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have heart disease shown by imaging to affect heart muscle function or show scarring.I have not had a recent heart attack or severe chest pain due to heart issues.I have severe heart failure or am expected to live less than a year without treatment for VT.I have a type of irregular heartbeat known as polymorphic VT or VF.I have had multiple specific heart rhythm problems despite treatment.I have had radiation treatment in the area likely to be treated again.
Research Study Groups:
This trial has the following groups:- Group 1: Imaging & SBRT Treatment for Ventricular Tachycardia
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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