- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04065802
Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia Management (STAR VTM)
Stereotactic Arrhythmia Radioablation (STAR) ablation is a safe and feasible option for cardiomyopathy patients for management of refractory ventricular tachycardia.
STAR can be performed with available cardiac imaging, prior mapping/electrogram information, and standard ECGs without a multi-electrode ECG vest.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Hypotheses:
- Stereotactic Arrhythmia Radioablation (STAR) ablation is a safe and feasible option for cardiomyopathy patients for management of refractory ventricular tachycardia.
- STAR can be performed with available cardiac imaging, prior mapping/electrogram information, and standard ECGs without a multi-electrode ECG vest.
Study Objectives:
- Evaluate the safety of STAR in a local cohort
- Estimate effectiveness of STAR in reducing VT burden
Study Design: Prospective single center, single arm, non-randomized trial.
Number of patients: 20 patients
Study Duration: Enrollment will occur over three years and at least minimum follow up of six months
Study Population: Adult patients with a cardiomyopathy and ventricular tachycardia who have failed conventional anti-arrhythmic management.
Primary safety endpoint: Any treatment-related serious adverse events in the first 90 days.
Primary efficacy endpoint: Reduction in VT episodes tracked by ICD with a six week blanking period.
Statistical methodology: Wilcoxon matched-pairs signed-ranks test to compare the number of treated episodes before and after.
Assessment of events: Adjudicated by study investigators
Economic Analysis: Costs and resources required for STAR .Compare costs between the patients undergoing STAR with conventional catheter-based VT ablation.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Vikas Kuriachan, MD
- Phone Number: 4039443282
- Email: vpkuriac@ucalgary.ca
Study Contact Backup
- Name: Stephen Wilton, MD
- Phone Number: 4032107102
- Email: sbwilton@ucalgary.ca
Study Locations
-
-
Alberta
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Calgary, Alberta, Canada, T2N 4Z6
- Recruiting
- University of Calgary
-
Contact:
- Jennifer Mckeage
- Phone Number: 4032106047
- Email: jmckeage@ucalgary.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
18 years of age and have an implanted cardioverter defibrillator (ICD) with:
- Structural heart disease: ischemic or non-ischemic cardiomyopathy diagnosed with cardiac imaging demonstrating either segmental myocardial dysfunction, or presence of scar.
- At least 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: Sustained monomorphic VT documented on 12-lead ECG or rhythm strip 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.
Exclusion Criteria:
- Has received prior radiotherapy to the anticipated treatment field
- Pregnancy
- Unable to unwilling to provide informed consent
- New York Heart Association class IV heart failure or inotrope use limiting the safe transport to the radiotherapy suite
- Patients in whom the only ventricular arrhythmias are ventricular fibrillation, torsade de pointes, or polymorphic ventricular tachycardia.
- Active coronary ischemia in the last 30 days.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Radioablation Treatment
Patients will receive radioablation to scar regions of the heart responsible for ventricular tachycardia
|
External, non-invasive radiation delivery to scar regions of heart to treat ventricular arrhythmias
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of radiation treatment for VT reduction
Time Frame: 6 month period before treatment to the 6 month period after ablation with a 6 week blanking period post-treatment.
|
Reduction in VT burden tracked by ICD and defined as the difference between the number of ICD-treated VT/VF episodes comparing the 6 months prior to treatment to the 6 months after treatment.
|
6 month period before treatment to the 6 month period after ablation with a 6 week blanking period post-treatment.
|
Safety composite endpoint of radiation treatment-related pericarditis, pneumonitis, changes in cardiac structures, function, and/or ICD function.
Time Frame: 90 days after treatment
|
Any treatment-related serious adverse events including pericarditis, radiation pneumonitis, deterioration in cardiac function, new or worsening cardiac valve dysfunction, and implantable cardioverter defibrillator malfunction.
|
90 days after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall mortality
Time Frame: Six months
|
Six month survival after treatment
|
Six months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Vikas Kuriachan, MD, University of Calgary
Publications and helpful links
General Publications
- Cuculich PS, Schill MR, Kashani R, Mutic S, Lang A, Cooper D, Faddis M, Gleva M, Noheria A, Smith TW, Hallahan D, Rudy Y, Robinson CG. Noninvasive Cardiac Radiation for Ablation of Ventricular Tachycardia. N Engl J Med. 2017 Dec 14;377(24):2325-2336. doi: 10.1056/NEJMoa1613773.
- Cuculich PS, Robinson CG. Noninvasive Ablation of Ventricular Tachycardia. N Engl J Med. 2018 Apr 26;378(17):1651-1652. doi: 10.1056/NEJMc1802625. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB19-1281
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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