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Recruiting NCT04843683

StereoTactic Ablative RadioTherapy of Cardiac Arrhythmias

No phase Interventional Cardiac Arrhythmia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stereotactic Ablative Radiotherapy.
Who it may be relevant to
Registry conditions: Cardiac Arrhythmia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

StereoTactic Ablative RadioTherapy of Cardiac Arrhythmias (START-CA): a Phase II Trial of Non-Invasive Treatment of Medically Refractory Patients

Overview

This is a prospective, single-center, phase II trial that will be monitoring the safety and efficacy of using stereotactic ablative radiotherapy (SBRT) to treat patients with a medical condition affecting heart rate and rhythm (refractory arrhythmias) within the University Health Network (Princess Margaret Cancer Centre and Toronto General Hospital). The primary objective will be to prospectively monitor patient cardiac outcomes following SBRT.

Interventions

  • Radiation Stereotactic Ablative Radiotherapy
    Stereotactic ablative radiotherapy (SBRT) is a type of radiation treatment that delivers precise, high dose radiation to targeted areas. In this study, a single treatment of SBRT will be delivered to the abnormal area of a participant's heart that is causing dangerous heart rate and rhythm changes (arrhythmia).

Primary outcome measures

  • Change from Baseline in ICD therapies. [Time frame: Baseline to 18 months follow-up.]
  • Change from Baseline in the number or dose of antiarrhythmic medications. [Time frame: Baseline to 18 months follow-up.]
Secondary outcome measures (6)
  • Measure patient quality-of-life during the study. [Time frame: Baseline to 18 months follow-up.]
  • Measure patient quality-of-life during the study. [Time frame: Baseline to 18 months follow-up.]
  • Measure patient subjective distress following treatment. [Time frame: Baseline to 6 months follow-up]
  • Overall mortality record. [Time frame: 6 to 18 months follow-up.]
  • Number of patients with acute and long-term toxicity as assessed by CTCAE v5.0. [Time frame: 1 month to 18 months follow-up.]
  • Rates of hospital admissions. [Time frame: Baseline to 18 months follow-up.]

Eligibility criteria

Inclusion criteria

  • Patients with heart rate and rhythm condition (arrhythmia) who have failed standard of care treatment with medication OR at least one prior invasive catheter ablation procedure.
  • Patients deemed medically fit to receive stereotactic ablative radiotherapy as determined by their Radiation Oncologist.

Exclusion criteria

  • Patients who have previously received high dose radiotherapy to the target area and cannot safely receive further treatment OR are unable to receive radiotherapy due to other contraindications.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Princess Margaret Cancer Center, University Health Network — Toronto

Identifiers

NCT: NCT04843683 · 20-6027

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗