Ignite Creation Date:
2024-05-06 @ 1:35 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04065802
Status:
RECRUITING
Last Update Posted:
2022-11-15
First Post:
2019-08-20
Brief Title:
Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia Management
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia Management
Status:
RECRUITING
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR VTM
Brief Summary:
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 mappingelectrogram information and standard ECGs without a multi-electrode ECG vest
STAR can be performed with available cardiac imaging prior mappingelectrogram information and standard ECGs without a multi-electrode ECG vest
Detailed Description:
Study Hypotheses
1 Stereotactic Arrhythmia Radioablation STAR ablation is a safe and feasible option for cardiomyopathy patients for management of refractory ventricular tachycardia
2 STAR can be performed with available cardiac imaging prior mappingelectrogram information and standard ECGs without a multi-electrode ECG vest
Study Objectives
1 Evaluate the safety of STAR in a local cohort
2 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
1 Stereotactic Arrhythmia Radioablation STAR ablation is a safe and feasible option for cardiomyopathy patients for management of refractory ventricular tachycardia
2 STAR can be performed with available cardiac imaging prior mappingelectrogram information and standard ECGs without a multi-electrode ECG vest
Study Objectives
1 Evaluate the safety of STAR in a local cohort
2 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None