Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia Management

NCT04065802 | Unknown DMC

• 1 other identifier: REB19-1281
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stereotactic Radioablation for Ventricular Tachycardia

Outcome Measures

Primary Outcomes (2)

• Efficacy of radiation treatment for VT reduction

  Reduction in VT burden tracked by ICD and defined as the difference between the number of ICD-treated VT/VF episodes comparing the 6 months prior to treatment to the 6 months after treatment.

  6 month period before treatment to the 6 month period after ablation with a 6 week blanking period post-treatment.

• Safety composite endpoint of radiation treatment-related pericarditis, pneumonitis, changes in cardiac structures, function, and/or ICD function.

  Any treatment-related serious adverse events including pericarditis, radiation pneumonitis, deterioration in cardiac function, new or worsening cardiac valve dysfunction, and implantable cardioverter defibrillator malfunction.

  90 days after treatment

Secondary Outcomes (1)

• Overall mortality

  Six months

Study Arms (1)

Radioablation Treatment

EXPERIMENTAL

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

Radiation: Stereotactic Radioablation

Interventions

Stereotactic Radioablation RADIATION

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

Radioablation Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and have an implanted cardioverter defibrillator (ICD) with:
• Structural heart disease: ischemic or non-ischemic cardiomyopathy diagnosed with cardiac imaging demonstrating either segmental myocardial dysfunction, or presence of scar.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead
• Libin Cardiovascular Institute of Alberta: collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

RECRUITING

Related Publications (2)

• 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.

  PMID: 29236642 RESULT

• 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.

  PMID: 29694814 RESULT

Study Officials

• Vikas Kuriachan, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vikas Kuriachan, MD

CONTACT

4039443282; vpkuriac@ucalgary.ca

Stephen Wilton, MD

CONTACT

4032107102; sbwilton@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor (Cardiology/EP)

Model Details: Adult patients with a cardiomyopathy and ventricular tachycardia who have failed conventional anti-arrhythmic management.

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: August 22, 2019
• Study Start: April 14, 2021
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2024
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)