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Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia Management (STAR VTM)

Primary Purpose

Stereotactic Radioablation for Ventricular Tachycardia

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Stereotactic Radioablation

About this trial

This is an interventional treatment trial for Stereotactic Radioablation for Ventricular Tachycardia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 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.

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.

Sites / Locations

University of CalgaryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radioablation Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Overall mortality

Six month survival after treatment

Full Information

NCT ID

NCT04065802

First Posted

August 20, 2019

Last Updated

November 13, 2022

Sponsor

University of Calgary

Collaborators

Libin Cardiovascular Institute of Alberta

1. Study Identification

Unique Protocol Identification Number

NCT04065802

Brief Title

Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia Management

Acronym

STAR VTM

Official Title

Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia Management

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 14, 2021 (Actual)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Calgary

Collaborators

Libin Cardiovascular Institute of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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: 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. Study Objectives: Evaluate the safety of STAR in a local cohort 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stereotactic Radioablation for Ventricular Tachycardia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Radioablation Treatment

Arm Type

Experimental

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

Stereotactic Radioablation

Intervention Description

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

Primary Outcome Measure Information:

Title

Efficacy of radiation treatment for VT reduction

Description

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.

Time Frame

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

Title

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

Description

Time Frame

90 days after treatment

Secondary Outcome Measure Information:

Title

Overall mortality

Description

Six month survival after treatment

Time Frame

Six months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Vikas Kuriachan, MD

Phone

4039443282

vpkuriac@ucalgary.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Stephen Wilton, MD

Phone

4032107102

sbwilton@ucalgary.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vikas Kuriachan, MD

Organizational Affiliation

University of Calgary

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Calgary

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4Z6

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jennifer Mckeage

Phone

4032106047

jmckeage@ucalgary.ca

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

The data will be anonymous. Given the small number of patients in the study individual treatments and outcomes maybe looked at.

Citations:

PubMed Identifier

29236642

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.

Results Reference

result

PubMed Identifier

29694814

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.

Results Reference

result

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Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia Management

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