Stereotactic Ablative Radiotherapy for Refractory Ventricular Tachycardia

Not Applicable

Completed

• Conditions: Refractory Ventricular Tachycardia
• Interventions: Radiation: Stereotactic Ablative Radiotherapy (SABR)

• Registration Number: NCT03349892
• Lead Sponsor: University of California, Los Angeles

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2017-11-17
• Study First Submitted QC: 2017-11-17
• Study First Posted: 2017-11-22
• Primary Completion: 2019-08-06
• Study Completion: 2019-08-06
• Results First Submitted: 2021-07-21
• Status Verified: 2021-10
• Results First Submitted QC: 2021-10-15
• Last Update Submitted: 2021-10-15
• Results First Posted: 2021-11-15
• Last Update Posted: 2021-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stereotactic Ablation Treatment Arm	Stereotactic Ablative Radiotherapy (SABR)	This is a single-arm, non-blinded study.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UCLA Department of Radiation Oncology; 🇺🇸 Los Angeles, California, United States