Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia Management (STAR VTM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04065802|
Recruitment Status : Not yet recruiting
First Posted : August 22, 2019
Last Update Posted : August 30, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Stereotactic Radioablation for Ventricular Tachycardia||Radiation: Stereotactic Radioablation||Not Applicable|
- 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.
- 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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Adult patients with a cardiomyopathy and ventricular tachycardia who have failed conventional anti-arrhythmic management.|
|Masking:||None (Open Label)|
|Official Title:||Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia Management|
|Estimated Study Start Date :||January 2020|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2024|
Experimental: Radioablation Treatment
Patients will receive radioablation to scar regions of the heart responsible for ventricular tachycardia
Radiation: Stereotactic Radioablation
External, non-invasive radiation delivery to scar regions of heart to treat ventricular arrhythmias
- 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.
- 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.
- Overall mortality [ Time Frame: Six months ]Six month survival after treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065802
|Contact: Vikas Kuriachan, MDfirstname.lastname@example.org|
|Contact: Stephen Wilton, MDemail@example.com|
|Principal Investigator:||Vikas Kuriachan, MD||University of Calgary|