Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT04065802
Status:
UNKNOWN
Last Update Posted:
2022-11-15
First Post:
2019-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia Management
Sponsor:
University of Calgary
Organization:
Study Overview
Official Title:
Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia Management
Status:
UNKNOWN
Status Verified Date:
2022-11
Last Known Status:
RECRUITING
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 mapping/electrogram information, and standard ECGs without a multi-electrode ECG vest.
STAR can be performed with available cardiac imaging, prior mapping/electrogram 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 mapping/electrogram 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 mapping/electrogram 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:
True
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?: