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NCT Number: NCT04843683

StereoTactic Ablative RadioTherapy of Cardiac Arrhythmias

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.

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Key information

Conditions

Cardiac Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Cancer Center, University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location status: Recruiting

Location contact

Benjamin Lok, MD

CONTACT

[email protected]

416-946-4501 ext. 5819

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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).

Primary outcomes

  1. 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.

  2. 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

  1. Measure patient quality-of-life during the study.

    Time frame: Baseline to 18 months follow-up.

    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).

  2. Measure patient quality-of-life during the study.

    Time frame: Baseline to 18 months follow-up.

    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).

  3. Measure patient subjective distress following treatment.

    Time frame: Baseline to 6 months follow-up

    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.

  4. Overall mortality record.

    Time frame: 6 to 18 months follow-up.

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

  5. Number of patients with acute and long-term toxicity as assessed by CTCAE v5.0.

    Time frame: 1 month to 18 months follow-up.

    Acute (less than or equal to 90 days) and long-term (greater than 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

  6. Rates of hospital admissions.

    Time frame: Baseline to 18 months follow-up.

    Safety will be evaluated by recording rates of hospital admission during the study.

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin Lok, MD

CONTACT

[email protected]

416-946-2919

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Acronym: START-CA

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Apr 13, 2021
Registry last updated
Mar 5, 2026

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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