StereoTactic Ablative RadioTherapy of Cardiac Arrhythmias (START-CA): a Phase II Trial of Non-Invasive Treatment of Medically Refractory Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiac Arrhythmia
- Sponsor
- University Health Network, Toronto
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change from Baseline in ICD therapies.
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
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.
Outcomes
Primary Outcomes
Change from Baseline in ICD therapies.
Time Frame: Baseline to 18 months follow-up.
Patient cardiac outcomes will be evaluated by changes from baseline in ICD (Implantable Cardioverter-Defibrillator) therapies (ICD shock frequency) following radiotherapy at 1, 3, 6, 12 and 18 months of follow-up.
Change from Baseline in the number or dose of antiarrhythmic medications.
Time Frame: Baseline to 18 months follow-up.
Patient cardiac outcomes will be evaluated by changes from baseline in the number or dose of antiarrhythmic medications following radiotherapy at 1, 3, 6, 12 and 18 months of follow-up.
Secondary Outcomes
- Number of patients with acute and long-term toxicity as assessed by CTCAE v5.0.(1 month to 18 months follow-up.)
- Measure patient subjective distress following treatment.(Baseline to 6 months follow-up)
- Overall mortality record.(6 to 18 months follow-up.)
- Rates of hospital admissions.(Baseline to 18 months follow-up.)
- Measure patient quality-of-life during the study.(Baseline to 18 months follow-up.)