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StereoTactic Ablative RadioTherapy of Cardiac Arrhythmias

ConditionCardiac Arrhythmia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Stereotactic Ablative Radiotherapy

    Radiation

    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).

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Stereotactic ablative radiotherapy (SBRT) ArmExperimental treatment 1 intervention
Group B: Observational ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change from Baseline in ICD therapies.

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.

Time frame
Baseline to 18 months follow-up.
2

Change from Baseline in the number or dose of antiarrhythmic medications.

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.

Time frame
Baseline to 18 months follow-up.

Secondary outcomes

1

Measure patient quality-of-life during the study.

Patient-Reported Health Related Quality of Life (HRQOL) will be assessed at each 1, 3, 6, 12 and 18 month follow-up, using the following assessment questionnaires: 36-item Short Form Health Survey (SF-36).

Time frame
Baseline to 18 months follow-up.
2

Measure patient quality-of-life during the study.

Patient-Reported Health Related Quality of Life (HRQOL) will be assessed at each 1, 3, 6, 12 and 18 month follow-up, using the following assessment questionnaire: the Hospital Anxiety and Depression Scale (HADS-A). A lower score indicates a better outcome. HADS-A Scoring: 0-7 = Normal, 8-10 = Borderline abnormal (borderline case), 11-21 = Abnormal (case).

Time frame
Baseline to 18 months follow-up.
3

Measure patient subjective distress following treatment.

Patient subjective distress following treatment will be measured at baseline, and 1 month and 6-months follow-up, using the Impact of Events Scale (IES-R). A higher score indicates a worse outcome. IES-R Scoring: 24 or more = Post-traumatic stress disorder (PTSD) is a clinical concern. 33 and above = This represents the best cutoff for a probable diagnosis of PTSD. 37 or more = This is high enough to suppress immune system's functioning.

Time frame
Baseline to 6 months follow-up
4

Overall mortality record.

Safety will be evaluated by recording overall mortality at 6 month intervals post-treatment.

Time frame
6 to 18 months follow-up.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Source ClinicalTrials.gov
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