Stereotactic Ablative Radiotherapy for Refractory Ventricular Tachycardia

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

NCT03349892•University of California, Los Angeles

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+2 more criteria

Locations (1)

UCLA Department of Radiation Oncology

Los Angeles, California, United States

Key Dates

Start Date

April 1, 2017

Primary Completion Date

August 6, 2019

Completion Date

August 6, 2019

Last Updated

November 15, 2021

Enrollment

ACTUAL participants

Conditions

Refractory Ventricular Tachycardia

Interventions

Stereotactic Ablative Radiotherapy (SABR)

RADIATION