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Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia Management (STAR VTM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04065802
Recruitment Status : Not yet recruiting
First Posted : August 22, 2019
Last Update Posted : August 30, 2019
Sponsor:
Collaborator:
Libin Cardiovascular Institute of Alberta
Information provided by (Responsible Party):
Vikas Kuriachan, University of Calgary

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.


Condition or disease Intervention/treatment Phase
Stereotactic Radioablation for Ventricular Tachycardia Radiation: Stereotactic Radioablation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Adult patients with a cardiomyopathy and ventricular tachycardia who have failed conventional anti-arrhythmic management.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia Management
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Radioablation Treatment
Patients will receive radioablation to scar regions of the heart responsible for ventricular tachycardia
Radiation: Stereotactic Radioablation
External, non-invasive radiation delivery to scar regions of heart to treat ventricular arrhythmias




Primary Outcome Measures :
  1. Efficacy of radiation treatment for VT reduction [ Time Frame: 6 month period before treatment to the 6 month period after ablation with a 6 week blanking period post-treatment. ]
    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.

  2. Safety composite endpoint of radiation treatment-related pericarditis, pneumonitis, changes in cardiac structures, function, and/or ICD function. [ Time Frame: 90 days after treatment ]
    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 :
  1. Overall mortality [ Time Frame: Six months ]
    Six month survival after treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065802


Contacts
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Contact: Vikas Kuriachan, MD 4039443282 vpkuriac@ucalgary.ca
Contact: Stephen Wilton, MD 4032107102 sbwilton@ucalgary.ca

Sponsors and Collaborators
University of Calgary
Libin Cardiovascular Institute of Alberta
Investigators
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Principal Investigator: Vikas Kuriachan, MD University of Calgary

Publications of Results:
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Responsible Party: Vikas Kuriachan, Clinical Associate Professor (Cardiology/EP), University of Calgary
ClinicalTrials.gov Identifier: NCT04065802     History of Changes
Other Study ID Numbers: REB19-1281
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data will be anonymous. Given the small number of patients in the study individual treatments and outcomes maybe looked at.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes