Stereotactic Ablative Radiotherapy (SAbR) for Treatment of Ventricular Tachycardia (VT) Refractory Standard Invasive Ablation Techniques

August 15, 2022 updated by: James Daniels, University of Texas Southwestern Medical Center
The purpose of this study is to evaluate the clinical efficacy and safety of stereotactic ablative radiotherapy (SAbR), also known as stereotactic body radiation therapy (SBRT), for treatment of ventricular tachycardia (VT) requiring implantable cardioverter defibrillator (ICD) treatments in patients with VT refractory to standard invasive ablation techniques. We hypothesized that SAbR is effective in suppressing sustained VT and reducing ICD treatments in this group of patients and is associated with acceptably low risk of serious complications.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • 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 Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center - Dallas

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Have an ICD implanted > 6 months and all VT episodes in the past 6 months are available in device memory.
  • Within the past 3 months, the patient has at least one episode of symptomatic monomorphic VT that requires ICD treatment (anti-tachycardia pacing and/or ICD shock) or was sustained/incessant but falls under ICD treatment zone. These VT episodes must occur after at least one standard invasive VT ablation or occur in a patient that is clinically deemed not eligible to the standard VT ablation procedure.
  • Two independent cardiac electrophysiologists reviewed the case and agreed that the patient would benefit from suppression of these VT episodes but there is no optimal invasive VT ablation or antiarrhythmic drug options.

Exclusion Criteria:

  • Has contraindication to receive SAbR or VT clinically deemed not suitable for SAbR.
  • Is pregnant
  • Has severe co-morbid medical condition or terminal illness and is unlikely to survive more than 6 months regardless of VT status based on clinical judgement by treating or enrolling physicians.
  • On potent immunosuppressive therapy (e.g., post organ transplant)
  • Has severe collagen vascular disorder with organ involvement
  • Not willing or not able to consent to participate in the study

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
Intervention / Treatment
Other: Arm
No arm
Radiation: Stereotactic ablative radiotherapy
Stereotactic ablative radiotherapy (SAbR) delivers of a potent, ablative or nearly ablative dose of radiation in oligofractions (ie, five or fewer fractions) primarily to create a compact dose delivered accurately to the intended target with steep gradients in all directions (geometric avoidance) and avoid damaging normal tissues.
Other Names:
  • SAbR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary efficacy outcome of ICD (implantable cardioverter-defibrillator) Treatment
Time Frame: 6 months
Number of episodes of ICD (implantable cardioverter-defibrillator) treatment (including both ATP and shock) per month; comparing 6 months before and after SAbR (excluding the first 2-week blanking period post SAbR).
6 months

Collaborators and Investigators

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

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: James Daniel, MD, UT Southwestern Medical Center

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 (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

March 1, 2025

Study Completion (Anticipated)

March 1, 2025

Study Registration Dates

First Submitted

February 20, 2020

First Submitted That Met QC Criteria

April 2, 2020

First Posted (Actual)

April 6, 2020

Study Record Updates

Last Update Posted (Actual)

August 17, 2022

Last Update Submitted That Met QC Criteria

August 15, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU-2019-1023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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