Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-25 @ 3:54 AM
NCT ID:
NCT04065802
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.
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.
Study:
NCT04065802
Study Brief:
Protocol Section:
NCT04065802