Status:
COMPLETED
Stereotactic Ablative Radiotherapy for Refractory Ventricular Tachycardia
Lead Sponsor:
University of California, Los Angeles
Conditions:
Refractory Ventricular Tachycardia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 6 2019
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03349892
Start Date
April 1 2017
End Date
August 6 2019
Last Update
November 15 2021
Active Locations (1)
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1
UCLA Department of Radiation Oncology
Los Angeles, California, United States, 90095-6951