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StereoTactic Ablative RadioTherapy of Cardiac Arrhythmias (START-CA)

Primary Purpose

Cardiac Arrhythmia

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Stereotactic Ablative Radiotherapy
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrhythmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Princess Margaret Cancer Center, University Health NetworkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Stereotactic ablative radiotherapy (SBRT) Arm

Observational Arm

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Measure patient quality-of-life during the study.
Patient-Reported Health Related Quality of Life (HRQOL) will be assessed at each 1, 3, 6, 12 and 18 month follow-up, using the following assessment questionnaires: 36-item Short Form Health Survey (SF-36).
Measure patient quality-of-life during the study.
Patient-Reported Health Related Quality of Life (HRQOL) will be assessed at each 1, 3, 6, 12 and 18 month follow-up, using the following assessment questionnaire: the Hospital Anxiety and Depression Scale (HADS-A). A lower score indicates a better outcome. HADS-A Scoring: 0-7 = Normal, 8-10 = Borderline abnormal (borderline case), 11-21 = Abnormal (case).
Measure patient subjective distress following treatment.
Patient subjective distress following treatment will be measured at baseline, and 1 month and 6-months follow-up, using the Impact of Events Scale (IES-R). A higher score indicates a worse outcome. IES-R Scoring: 24 or more = Post-traumatic stress disorder (PTSD) is a clinical concern. 33 and above = This represents the best cutoff for a probable diagnosis of PTSD. 37 or more = This is high enough to suppress immune system's functioning.
Overall mortality record.
Safety will be evaluated by recording overall mortality at 6 month intervals post-treatment.
Number of patients with acute and long-term toxicity as assessed by CTCAE v5.0.
Acute (less than or equal to 90 days) and long-term (greater than 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Rates of hospital admissions.
Safety will be evaluated by recording rates of hospital admission during the study.

Full Information

First Posted
April 1, 2021
Last Updated
April 5, 2023
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT04843683
Brief Title
StereoTactic Ablative RadioTherapy of Cardiac Arrhythmias (START-CA)
Official Title
StereoTactic Ablative RadioTherapy of Cardiac Arrhythmias (START-CA): a Phase II Trial of Non-Invasive Treatment of Medically Refractory Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrhythmia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stereotactic ablative radiotherapy (SBRT) Arm
Arm Type
Experimental
Arm Description
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).
Arm Title
Observational Arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Ablative Radiotherapy
Intervention Description
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 Information:
Title
Change from Baseline in ICD therapies.
Description
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.
Time Frame
Baseline to 18 months follow-up.
Title
Change from Baseline in the number or dose of antiarrhythmic medications.
Description
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.
Time Frame
Baseline to 18 months follow-up.
Secondary Outcome Measure Information:
Title
Measure patient quality-of-life during the study.
Description
Patient-Reported Health Related Quality of Life (HRQOL) will be assessed at each 1, 3, 6, 12 and 18 month follow-up, using the following assessment questionnaires: 36-item Short Form Health Survey (SF-36).
Time Frame
Baseline to 18 months follow-up.
Title
Measure patient quality-of-life during the study.
Description
Patient-Reported Health Related Quality of Life (HRQOL) will be assessed at each 1, 3, 6, 12 and 18 month follow-up, using the following assessment questionnaire: the Hospital Anxiety and Depression Scale (HADS-A). A lower score indicates a better outcome. HADS-A Scoring: 0-7 = Normal, 8-10 = Borderline abnormal (borderline case), 11-21 = Abnormal (case).
Time Frame
Baseline to 18 months follow-up.
Title
Measure patient subjective distress following treatment.
Description
Patient subjective distress following treatment will be measured at baseline, and 1 month and 6-months follow-up, using the Impact of Events Scale (IES-R). A higher score indicates a worse outcome. IES-R Scoring: 24 or more = Post-traumatic stress disorder (PTSD) is a clinical concern. 33 and above = This represents the best cutoff for a probable diagnosis of PTSD. 37 or more = This is high enough to suppress immune system's functioning.
Time Frame
Baseline to 6 months follow-up
Title
Overall mortality record.
Description
Safety will be evaluated by recording overall mortality at 6 month intervals post-treatment.
Time Frame
6 to 18 months follow-up.
Title
Number of patients with acute and long-term toxicity as assessed by CTCAE v5.0.
Description
Acute (less than or equal to 90 days) and long-term (greater than 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time Frame
1 month to 18 months follow-up.
Title
Rates of hospital admissions.
Description
Safety will be evaluated by recording rates of hospital admission during the study.
Time Frame
Baseline to 18 months follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin Lok, MD
Phone
416-946-2919
Email
benjamin.lok@rmp.uhn.ca
Facility Information:
Facility Name
Princess Margaret Cancer Center, University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Lok, MD
Phone
416-946-4501
Ext
5819
Email
Benjamin.Lok@rmp.uhn.ca

12. IPD Sharing Statement

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StereoTactic Ablative RadioTherapy of Cardiac Arrhythmias (START-CA)

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