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Radiation Therapy

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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in ICD therapies.
Change from Baseline in the number or dose of antiarrhythmic medications.
Secondary outcome measures
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

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.

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,476 Previous Clinical Trials
485,120 Total Patients Enrolled

Media Library

Stereotactic Ablative Radiotherapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04843683 — N/A
Arrhythmia Research Study Groups: Observational Arm, Stereotactic ablative radiotherapy (SBRT) Arm
Arrhythmia Clinical Trial 2023: Stereotactic Ablative Radiotherapy Highlights & Side Effects. Trial Name: NCT04843683 — N/A
Stereotactic Ablative Radiotherapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04843683 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide an overview of the population size involved in this research?

"Affirmative, the information posted on clinicaltrials.gov shows that this trial is currently in search of participants. This research was first revealed on December 14th 2021 and has most recently been updated October 31st 2022; with a total of 60 patients wished to be recruited from 1 medical location."

Answered by AI

What is the primary aim of this research?

"This clinical trial will assess changes from baseline to 18 months follow-up in ICD therapies. Secondary objectives include assessing rates of hospital admission and evaluating patient quality-of-life using the Hospital Anxiety and Depression Scale (HADS-A). Additionally, acute and long-term toxicity as assessed by CTCAE v5.0 will be monitored for safety outcomes."

Answered by AI

Does this trial still have open registration?

"As per the information accessible on clinicaltrials.gov, this trial is still open for recruitment and was initially announced to the public on December 14th 2021; with its most recent update posted at October 31st 2022."

Answered by AI
~12 spots leftby Dec 2024