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

Tachycardia, Ventricular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04334811
• Other study ID #: STU-2019-1023
• Status: Withdrawn
• Phase: N/A
• Start date: February 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: August 2022
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular

Intervention

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.

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center - Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary efficacy outcome of ICD (implantable cardioverter-defibrillator) Treatment	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