Stereotactic Ablative Radiotherapy for Refractory Ventricular Tachycardia

Refractory Ventricular Tachycardia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03349892
• Other study ID #: Cardiac SABR
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: August 6, 2019

Study information

• Verified date: October 2021
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: August 6, 2019
• Est. primary completion date: August 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Refractory Ventricular Tachycardia
• Tachycardia
• Tachycardia, Ventricular

Intervention

Radiation:
• Stereotactic Ablative Radiotherapy (SABR)
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.

Locations

Country	Name	City	State
United States	UCLA Department of Radiation Oncology	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Decline of LV Ejection Fraction by More Than 5% on Two Consecutive Echocardiograms	Incidence of decline of LV ejection fraction by more than 5% on two consecutive echocardiograms over 5 years	5 years
Other	Incidence of Persistent Increase in Baseline Supplemental Oxygen Requirement by 1L for a Duration of >3 Months	Incidence of persistent increase in baseline supplemental oxygen requirement by 1L for a duration of >3 months over 5 years	5 years
Other	Incidence of Steroid Use for Radiotherapy Related Indications		5 years
Other	Overall Survival		Followed for 10 years +
Primary	ICD (Implantable Cardioverter Defibrillator) Shock Free Survival	ICD (implantable cardioverter defibrillator) shock free survival at six months	6 months
Primary	Incidence of Salvage Definitive Anti-arrhythmia Therapy (Cardiac Transplant)	Incidence of salvage definitive anti-arrhythmia therapy (cardiac transplant) over 5 years.	5 years
Secondary	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	5 years
Secondary	Incidence of ICD Shocks	Incidence of ICD shocks 12 months post-SABR procedure	12 months post-SABR procedure