Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 3A7, Canada
Location status: Recruiting
Location contact
Gillian Schraefel, RN
CONTACT
John L Sapp, MD FRCPC
PRINCIPAL_INVESTIGATOR
NCT Number: NCT04162171
Ventricular tachycardia (VT) contributes to over 350,000 sudden deaths each year in the US. Malignant VTs involve an electrical "short circuit" in the heart, formed by narrow channels of surviving tissue inside myocardial scar. Current treatment for VT consists of either implantable defibrillators (ICDs), suppressive drug therapy, catheter ablation or a combination of all 3.
Implantable Defibrillators (ICDs) reduce sudden death and can terminate some ventricular tachycardia (VT) without shocks, but they don't prevent VT. The occurrence of ≥1 ICD shock is associated with reductions in mental well-being and physical functioning, and increases in anxiety and sometimes depression. Further, ICD shocks have been consistently associated with adverse outcomes, including heart failure and death. Furthermore, the most important predictor of ICD shocks is a history of prior ICD shocks.
Therapies to suppress VT include antiarrhythmic drug therapy and catheter ablation, neither however is universally effective. When VT recurs despite antiarrhythmic drug therapy and catheter ablation, novel yet invasive, approaches may be required. Such invasive procedures carry consequent risks of cardiac and extra-cardiac injury.
Stereotactic body radiotherapy (SBRT) is a non-invasive technique that delivers high doses of radiation precisely to specified regions in the body, while minimizing exposure to adjacent tissue. This technique is currently, and commonly used in the treatment of cancer. Conventional application of SBRT has made use of its ability to spare non-target tissue, including for treatment of tumors near the heart. More recently, clinicians have changed the paradigm, by focusing radioablative energy on ventricular scar responsible for ventricular tachycardia. Pre-clinical studies have supported the concept and were followed by first-in-human VT therapeutic experience in 2017. Subsequent studies have had encouraging results for patients who failed or were unable to tolerate conventional treatment.
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Halifax, Nova Scotia, B3H 3A7, Canada
Location status: Recruiting
Gillian Schraefel, RN
CONTACT
John L Sapp, MD FRCPC
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Additional imaging for SBRT planning and implementation:
Other names: VT Radioablation
Time frame: During the first 6 months post blanking period vs. 6 months prior to treatment.
Number of patients with a reduction in the absolute number of ventricular arrhythmia events following ablation and blanking period, in comparison with those prior to treatment.
Time frame: From time of enrollment to 7.5 ,months post treatment.
Effectiveness of different myocardial substrate targeting methods on sparing non-target tissue. Delivered treatment approach as compared to a proposed calculated treatment plan using a single phase of the 4DcCT. Measured differences between 2 target-method volumes will equate to the volume of sparred tissue.
Time frame: Through study completion,min of 7.5 months to max of 2 years.
Composite of; all cause mortality, pericarditis, pneumonitis, heart failure hospitalization and extra-cardiac injury.
Time frame: Through study completion,min of 7.5 months to max of 2 years
Composite of; appropriate ICD shock, VT storm, incessant VT, sustained VT below ICD detection and appropriate antitachycardia pacing.
Time frame: During 6 months prior vs. 6 months following treatment.
Composite of; number of appropriate shocks, number of inappropriate shocks, number of antitachycardia pacing events.
Contact information is provided by the study sponsor or research team.
John Sapp, MD FRCPC
CONTACT
Karen Giddens
CONTACT
John Sapp
Other
Noninvasive Cardiac Radioablation for Ventricular Tachycardia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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