Clinical trial NCT04065802: Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia Management
Official title: Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia Management
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stereotactic Radioablation for Ventricular Tachycardia
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Libin Cardiovascular Institute of Alberta
First posted: 2019-08-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Adult patients with a cardiomyopathy and ventricular tachycardia who have failed conventional anti-arrhythmic management.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

18 years of age and have an implanted cardioverter defibrillator (ICD) with:

1. Structural heart disease: ischemic or non-ischemic cardiomyopathy diagnosed with cardiac imaging demonstrating either segmental myocardial dysfunction, or presence of scar.
2. At least one of the following monomorphic VT events despite prior attempted catheter ablation (or contraindication for ablation), and despite treatment with a class III antiarrhythmic drug (contraindicated, ineffective or not tolerated):

A: Sustained monomorphic VT documented on 12-lead ECG or rhythm strip terminated by pharmacologic means, DC cardioversion or manual ICD Therapy.

B: ≥3 episodes of monomorphic VT treated with antitachycardia pacing (ATP), at least one of which was symptomatic C: ≥ 5 episodes of monomorphic VT treated with antitachycardia pacing (ATP) regardless of symptoms D: ≥1 appropriate ICD shocks, E: ≥3 monomorphic VT episodes within 24 hours VT events must be confirmed by ECG/monitor or ICD download.

Exclusion Criteria:

* Has received prior radiotherapy to the anticipated treatment field
* Pregnancy
* Unable to unwilling to provide informed consent
* New York Heart Association class IV heart failure or inotrope use limiting the safe transport to the radiotherapy suite
* Patients in whom the only ventricular arrhythmias are ventricular fibrillation, torsade de pointes, or polymorphic ventricular tachycardia.
* Active coronary ischemia in the last 30 days.

Primary outcomes:
measure: Efficacy of radiation treatment for VT reduction
timeFrame: 6 month period before treatment to the 6 month period after ablation with a 6 week blanking period post-treatment.
measure: Safety composite endpoint of radiation treatment-related pericarditis, pneumonitis, changes in cardiac structures, function, and/or ICD function.
timeFrame: 90 days after treatment
Secondary outcomes:
measure: Overall mortality
timeFrame: Six months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Vikas Kuriachan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cuculich PS, Schill MR, Kashani R, Mutic S, Lang A, Cooper D, Faddis M, Gleva M, Noheria A, Smith TW, Hallahan D, Rudy Y, Robinson CG. Noninvasive Cardiac Radiation for Ablation of Ventricular Tachycardia. N Engl J Med. 2017 Dec 14;377(24):2325-2336. doi: 10.1056/NEJMoa1613773.
citation: Cuculich PS, Robinson CG. Noninvasive Ablation of Ventricular Tachycardia. N Engl J Med. 2018 Apr 26;378(17):1651-1652. doi: 10.1056/NEJMc1802625. No abstract available.