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

NCT04334811 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-08-17

No results posted yet for this study

Summary

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.

Conditions

  • Tachycardia, Ventricular

Interventions

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.

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • James Daniel, MD · UT Southwestern Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2025-03-01
Completion
2025-03-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04334811 on ClinicalTrials.gov