Stereotactic Ablative Radiotherapy for Refractory Ventricular Tachycardia

NCT03349892 | Completed Results FDA Device

• 1 other identifier: Cardiac SABR
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractory Ventricular Tachycardia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Incidence of Return of Ventricular Tachycardia Requiring Defibrillation, Intravenous Drug Therapy or Readmission to Hospital

  5 years

• Incidence of ICD Shocks

  12 months post-SABR procedure

Other Outcomes (4)

• Incidence of Decline of LV Ejection Fraction by More Than 5% on Two Consecutive Echocardiograms

  5 years

• Incidence of Persistent Increase in Baseline Supplemental Oxygen Requirement by 1L for a Duration of >3 Months

  5 years

• Incidence of Steroid Use for Radiotherapy Related Indications

  5 years

Study Arms (1)

Stereotactic Ablation Treatment Arm

EXPERIMENTAL

This is a single-arm, non-blinded study.

Radiation: Stereotactic Ablative Radiotherapy (SABR)

Interventions

Stereotactic Ablative Radiotherapy (SABR) RADIATION

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.

Also known as: external beam radiation

Stereotactic Ablation Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Department of Radiation Oncology

Los Angeles, California, 90095-6951, United States

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Robert K. Chin, MD, PhD , Assistant Clinical Professor
• Organization: University of California, Los Angeles

rkchin@mednet.ucla.edu

(310) 825-9771

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: November 22, 2017
• Study Start: April 1, 2017
• Primary Completion: August 6, 2019
• Study Completion: August 6, 2019
• Last Updated: November 15, 2021
• Results First Posted: November 15, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)