Stereotactic Ablative Radiotherapy for Refractory Ventricular Tachycardia

Stereotactic Ablative Radiotherapy (SABR) for Refractory Ventricular Tachycardia - a Phase I/II Study

Single arm, phase Ib/2a dose escalation study with an expansion cohort to determine the maximal tolerated dose (MTD) for stereotactic ablative radiotherapy of targets in the cardiac myocardium and to make a preliminary assessment of the efficacy of the treatment. The dose escalation will be guided by Time-to-Event Continual Reassessment Method (TITE-CRM) to ensure more patients will be spared dose limiting toxicities and more patients will be entered on the dose level that will be chosen as minimal dose of maximal effect. This design also allows for continual accrual of patients when delayed adverse events may be observed.

Study Overview

• Status: Completed
• Conditions: Refractory Ventricular Tachycardia
• Intervention / Treatment: Radiation: Stereotactic Ablative Radiotherapy (SABR)

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095-6951
      • UCLA Department of Radiation Oncology

Participation Criteria

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:

Documented sustained ventricular arrhythmias refractory to or not a suitable candidate for catheter based RFA ablative therapy

• Documented sustained ventricular arrhythmias refractory to or not a suitable candidate for cardiac sympathetic denervation therapy
• Documented ventricular arrhythmias refractory to or not a suitable candidate for cardiac transplantation
• Documented sustained ventricular arrhythmias refractory to or not a suitable candidate for additional medical management
• ICD in place with documented episodes recurrent VT despite best clinical management previous refusal of ICD with recurrent sustained ventricular arrhythmias
• If ischemic cardiomyopathy, myocardial infarction occurred more than one month prior to enrollment
• No history of prior radiotherapy to the chest
• Prescribed dose must be deliverable using SABR technique
• Age ≥ 18 years
• Karnofsky Performance Status (KPS) > 70
• If a woman is of childbearing potential, a negative serum pregnancy test must be documented. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for at least 4 weeks after study treatment.
• Ability to understand and willingness to sign a written informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stereotactic Ablation Treatment Arm; This is a single-arm, non-blinded study.	Radiation: Stereotactic Ablative Radiotherapy (SABR); A single fraction of radiation is delivered using a clinical radiotherapy system capable of stereotactic radiotherapy to the chest, with on-board image guided radiotherapy capabilities, respiratory motion management, and Intensity Modulated Radiotherapy Treatment (IMRT) planning.; Other Names: external beam radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICD (Implantable Cardioverter Defibrillator) Shock Free Survival	ICD (implantable cardioverter defibrillator) shock free survival at six months	6 months
Incidence of Salvage Definitive Anti-arrhythmia Therapy (Cardiac Transplant)	Incidence of salvage definitive anti-arrhythmia therapy (cardiac transplant) over 5 years.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Return of Ventricular Tachycardia Requiring Defibrillation, Intravenous Drug Therapy or Readmission to Hospital	Incidence of return of ventricular tachycardia requiring defibrillation, intravenous drug therapy or readmission to hospital over 5 years	5 years
Incidence of ICD Shocks	Incidence of ICD shocks 12 months post-SABR procedure	12 months post-SABR procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Decline of LV Ejection Fraction by More Than 5% on Two Consecutive Echocardiograms	Incidence of decline of LV ejection fraction by more than 5% on two consecutive echocardiograms over 5 years	5 years
Incidence of Persistent Increase in Baseline Supplemental Oxygen Requirement by 1L for a Duration of >3 Months	Incidence of persistent increase in baseline supplemental oxygen requirement by 1L for a duration of >3 months over 5 years	5 years
Incidence of Steroid Use for Radiotherapy Related Indications		5 years
Overall Survival		Followed for 10 years +

Collaborators and Investigators

• Sponsor: University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): August 6, 2019
• Study Completion (Actual): August 6, 2019

Study Registration Dates

• First Submitted: November 17, 2017
• First Submitted That Met QC Criteria: November 17, 2017
• First Posted (Actual): November 22, 2017

Study Record Updates

• Last Update Posted (Actual): November 15, 2021
• Last Update Submitted That Met QC Criteria: October 15, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: Cardiac SABR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No