StereoTactic Ablative RadioTherapy of Cardiac Arrhythmias

NCT04843683 | Recruiting

• 1 other identifier: 20-6027
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrhythmia

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline to 18 months follow-up.

• 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.

  Baseline to 18 months follow-up.

Secondary Outcomes (6)

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

  Baseline to 18 months follow-up.

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

  Baseline 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.

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

  1 month to 18 months follow-up.

Study Arms (2)

Stereotactic ablative radiotherapy (SBRT) Arm

EXPERIMENTAL

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).

Radiation: Stereotactic Ablative Radiotherapy

Observational Arm

NO INTERVENTION

Potential participants who are eligible to be included in the study, but who choose not to have the SBRT procedure, can still receive standard medical treatment alone and be followed up with study visits and questionnaires.

Interventions

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).

Stereotactic ablative radiotherapy (SBRT) Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Center, University Health Network

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Benjamin Lok, MD

CONTACT

416-946-2919; benjamin.lok@rmp.uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 13, 2021
• Study Start: December 14, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

CA (1)