Recruiting

SBRT

Sponsor:

University Health Network, Toronto

Code:

NCT04843683

Conditions

Cardiac Arrhythmia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stereotactic Ablative Radiotherapy

Study Details

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

Study ID

NCT04843683

Start date

Dec 14, 2021

Status verified date

Mar, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Stereotactic ablative radiotherapy (SBRT) Arm

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).

no intervention: Observational Arm

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

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 measure

  • 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. ]

Central Contacts and Locations

Central contacts

Benjamin Lok, MD

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

Locations

Princess Margaret Cancer Center, University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Benjamin Lok, MD

416-946-4501Benjamin.Lok@rmp.uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-03-05.