Status:
WITHDRAWN
Stereotactic Ablative Radiotherapy (SAbR) for Treatment of Ventricular Tachycardia (VT) Refractory Standard Invasive Ablation Techniques
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Tachycardia, Ventricular
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ventr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04334811
Start Date
February 1 2023
End Date
March 1 2025
Last Update
August 17 2022
Active Locations (1)
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1
University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390