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Stereotactic Ablative Radiotherapy for Refractory Ventricular Tachycardia

Primary Purpose

Refractory Ventricular Tachycardia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Stereotactic Ablative Radiotherapy (SABR)

About this trial

This is an interventional treatment trial for Refractory Ventricular Tachycardia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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
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

Sites / Locations

UCLA Department of Radiation Oncology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stereotactic Ablation Treatment Arm

Arm Description

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

Outcomes

Primary Outcome Measures

ICD (Implantable Cardioverter Defibrillator) Shock Free Survival

ICD (implantable cardioverter defibrillator) shock free survival at six months

Incidence of Salvage Definitive Anti-arrhythmia Therapy (Cardiac Transplant)

Incidence of salvage definitive anti-arrhythmia therapy (cardiac transplant) over 5 years.

Secondary Outcome Measures

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

Incidence of ICD Shocks

Incidence of ICD shocks 12 months post-SABR procedure

Full Information

NCT ID

NCT03349892

First Posted

November 17, 2017

Last Updated

October 15, 2021

Sponsor

University of California, Los Angeles

1. Study Identification

Unique Protocol Identification Number

NCT03349892

Brief Title

Stereotactic Ablative Radiotherapy for Refractory Ventricular Tachycardia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

April 1, 2017 (Actual)

Primary Completion Date

August 6, 2019 (Actual)

Study Completion Date

August 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Refractory Ventricular Tachycardia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stereotactic Ablation Treatment Arm

Arm Type

Experimental

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

Stereotactic Ablative Radiotherapy (SABR)

Other Intervention Name(s)

external beam radiation

Intervention Description

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.

Primary Outcome Measure Information:

Title

ICD (Implantable Cardioverter Defibrillator) Shock Free Survival

Description

ICD (implantable cardioverter defibrillator) shock free survival at six months

Time Frame

6 months

Title

Incidence of Salvage Definitive Anti-arrhythmia Therapy (Cardiac Transplant)

Description

Incidence of salvage definitive anti-arrhythmia therapy (cardiac transplant) over 5 years.

Time Frame

5 years

Secondary Outcome Measure Information:

Title

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

Description

Incidence of return of ventricular tachycardia requiring defibrillation, intravenous drug therapy or readmission to hospital over 5 years

Time Frame

5 years

Title

Incidence of ICD Shocks

Description

Incidence of ICD shocks 12 months post-SABR procedure

Time Frame

12 months post-SABR procedure

Other Pre-specified Outcome Measures:

Title

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

Description

Incidence of decline of LV ejection fraction by more than 5% on two consecutive echocardiograms over 5 years

Time Frame

5 years

Title

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

Description

Incidence of persistent increase in baseline supplemental oxygen requirement by 1L for a duration of >3 months over 5 years

Time Frame

5 years

Title

Incidence of Steroid Use for Radiotherapy Related Indications

Time Frame

5 years

Title

Overall Survival

Time Frame

Followed for 10 years +

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

UCLA Department of Radiation Oncology

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095-6951

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Stereotactic Ablative Radiotherapy for Refractory Ventricular Tachycardia

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