Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia Management (STAR VTM)

November 13, 2022 updated by: Vikas Kuriachan, University of Calgary

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Recruiting
        • University of Calgary
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.
90 days after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall mortality
Time Frame: Six months
Six month survival after treatment
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Calgary

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Libin Cardiovascular Institute of Alberta

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vikas Kuriachan, MD, University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 14, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REB19-1281

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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