Radiotherapy for Arrhythmias

N/A

Recruiting

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 to 18 months follow-up.

Awards & highlights

No Placebo-Only Group

Summary

This trial 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).

Who is the study for?

The START-CA trial is for patients with stubborn heart rate and rhythm problems (arrhythmias) who haven't improved after standard treatments or at least one invasive procedure. They must be healthy enough for stereotactic ablative radiotherapy, as judged by a Radiation Oncologist, but can't join if they've had high dose radiotherapy to the target area before or have other reasons they can't undergo this therapy.

What is being tested?

This phase II trial at University Health Network is testing how safe and effective it is to use stereotactic ablative radiotherapy (SBRT) on patients with refractory arrhythmias. It's a forward-looking study that will closely watch how patients' hearts do after getting SBRT.

What are the potential side effects?

While specific side effects are not listed here, SBRT could potentially cause damage to nearby organs or tissues due to its precise high-dose radiation beams aimed at treating arrhythmias.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 to 18 months follow-up.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 to 18 months follow-up.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 to 18 months follow-up. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline in ICD therapies.

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

Secondary study objectives

Measure patient quality-of-life during the study.

Measure patient subjective distress following treatment.

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

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Stereotactic ablative radiotherapy (SBRT) ArmExperimental Treatment1 Intervention

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 II: Observational ArmActive Control1 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.

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