StereoTactic Ablative RadioTherapy of Cardiac Arrhythmias (START-CA)

NCT ID: NCT04843683

Last Updated: 2025-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-14

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Arrhythmia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

Stereotactic Ablative Radiotherapy

Intervention Type 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).

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Princess Margaret Cancer Center, University Health Network

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Benjamin Lok, MD

Role: CONTACT

416-946-2919

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Benjamin Lok, MD

Role: primary

416-946-4501 ext. 5819

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20-6027

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.