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Completed

NCT Number: NCT03349892

Stereotactic Ablative Radiotherapy for Refractory Ventricular Tachycardia

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Department of Radiation Oncology

Los Angeles, California, 90095-6951, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: external beam radiation

Primary outcomes

  1. ICD (Implantable Cardioverter Defibrillator) Shock Free Survival

    Time frame: 6 months

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

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

    Time frame: 5 years

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

Secondary outcomes

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

    Time frame: 5 years

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

  2. Incidence of ICD Shocks

    Time frame: 12 months post-SABR procedure

    Incidence of ICD shocks 12 months post-SABR procedure

Other outcomes

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

    Time frame: 5 years

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

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

    Time frame: 5 years

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

  3. Incidence of Steroid Use for Radiotherapy Related Indications

    Time frame: 5 years

  4. Overall Survival

    Time frame: Followed for 10 years +

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 22, 2017
Registry last updated
Nov 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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