N/A N=1 Treatment

Stereotactic Ablative Radiotherapy for Refractory Ventricular Tachycardia

Refractory Ventricular Tachycardia

Bottom Line

View on ClinicalTrials.gov: NCT03349892 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2021

Primary outcome: Primary: ICD (Implantable Cardioverter Defibrillator) Shock Free Survival — 1 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Stereotactic Ablative Radiotherapy (SABR) (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of California, Los Angeles
Primary completion: Aug 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY ICD (Implantable Cardioverter Defibrillator) Shock Free Survival	1	—
PRIMARY Incidence of Salvage Definitive Anti-arrhythmia Therapy (Cardiac Transplant)	—	—
SECONDARY Incidence of Return of Ventricular Tachycardia Requiring Defibrillation, Intravenous Drug Therapy or Readmission to Hospital	—	—
SECONDARY Incidence of ICD Shocks	1	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03349892). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.