Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia Management

NCT ID: NCT04065802

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-14
• Study Completion Date: 2024-12-30

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.

Conditions

Stereotactic Radioablation for Ventricular Tachycardia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radioablation Treatment

Patients will receive radioablation to scar regions of the heart responsible for ventricular tachycardia

Group Type: EXPERIMENTAL

Stereotactic Radioablation

Intervention Type: RADIATION

External, non-invasive radiation delivery to scar regions of heart to treat ventricular arrhythmias

Interventions

Stereotactic Radioablation

External, non-invasive radiation delivery to scar regions of heart to treat ventricular arrhythmias

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Libin Cardiovascular Institute of Alberta

OTHER

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Vikas Kuriachan

Clinical Associate Professor (Cardiology/EP)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vikas Kuriachan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

University of Calgary

Calgary, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Vikas Kuriachan, MD

Role: CONTACT

vpkuriac@ucalgary.ca

4039443282

Stephen Wilton, MD

Role: CONTACT

sbwilton@ucalgary.ca

4032107102

Facility Contacts

Jennifer Mckeage

Role: primary

jmckeage@ucalgary.ca

4032106047

References

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.

Reference Type: RESULT

PMID: 29236642 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29694814 (View on PubMed)

Other Identifiers

REB19-1281

Identifier Type: -

Identifier Source: org_study_id