NCT04065802

Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia Management

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Stereotactic Radioablation for Ventricular Tachycardia

Interventions

Type	Name	Description
RADIATION	Stereotactic Radioablation	External, non-invasive radiation delivery to scar regions of heart to treat ventricular arrhythmias

Timeline

• Start date: 2021-04-14
• Primary completion: 2023-12-30
• Completion: 2024-12-30
• First posted: 2019-08-22
• Last updated: 2022-11-15

Locations

1 site across 1 country: Canada