Cohort Study - SBRT for VT Radioablation
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Heart Disease Structural Disorder
- Myocardial Infarction
- Ventricular Tachycardia
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
Description
This will be a single centre single arm prospective cohort study. 12 patients with ventricular tachycardia will be recruited from those who have failed or were unable to tolerate conventional therapy. These patients will be recruited from the cardiology clinic where they will already be under the ca...
This will be a single centre single arm prospective cohort study. 12 patients with ventricular tachycardia will be recruited from those who have failed or were unable to tolerate conventional therapy. These patients will be recruited from the cardiology clinic where they will already be under the care of a heart rhythm/heart function specialist. Clinical imaging data, medical history and previous ablation data will be collected and use towards planning their treatment with SBRT. Patients will undergo further imaging (unless recently done clinically), including: 4D cardiac CT (cCT), cardiac MRI (cMRI) and a planning CT (pCT). MRIs will only be performed on patients with ICDs for whom it is considered safe to do so. Using the imaging and electroanatomic substrate mapping data collected from a previous ablation attempt, a volumetric modulated arc therapy (VMAT) treatment plan will be established. This treatment plan will be generated in consultation between the cardiac electrophysiologist, radiation oncologist and medical physicist; and will define the target volume (TV) of myocardial tissue to be treated. Once a TV has been established and verified, patients will be set up on a TrueBeam 1 linear accelerator where the treatment will be administered. The actual time for treatment administration is approximately 30 minutes. After the procedure, at 6 & 12 weeks, 7.5 months then every 6 months, a follow-up will occur as a part of standard care where outcome data regarding the chronic success of the ablation procedure will be collected and ICD interrogation will be performed. No imaging or mapping is planned at the follow-up. Patients will be followed for a minimum of 7.5 months to a maximum of 2 years depending on when they are enrolled.
Tracking Information
- NCT #
- NCT04162171
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: John Sapp, MD FRCPC Nova Scotia Health Authority Study Director: James Clarke, MD FRCPC Nova Scotia Health Authority Study Director: James Robar, Phd FCCPM Nova Scotia Health Authority Study Director: Jean-Philippe Pignol, MD FRCPC Nova Scotia Health Authority