Aortic StenosisCAN3TNCT06551610
CAN3T - Canadian TAVI Triage Tool
A study testing Triage Tool in people with Aortic Stenosis, run by Sunnybrook Health Sciences Centre.
Trial summary
The goal of this trial is to see if a tool that may reduce wait times will reduce bad outcomes in participants on the TAVI waitlist. The main questions it aims to answer are: How many deaths, hospitalizations, or urgent TAVI procedures take place while participants wait Days alive and out of hospital at 30 days and 12… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Triage Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,060 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients referred for TAVI who are 18 years or older at one of 11 TAVI hospitals
Who cannot join
- Any inpatient referrals who have an urgent inpatient TAVI on the same admission
- Any referral during the 1-month transition period
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Step-Wedged Cluster Randomized Registry-Based Multi-Centre Trial to Compare the Efficacy Between the Canadian TAVI Triage Tool and Standard of Care in TAVI Patients in Ontario, Canada
The goal of this trial is to see if a tool that may reduce wait times will reduce bad outcomes in participants on the TAVI waitlist. The main questions it aims to answer are:
- How many deaths, hospitalizations, or urgent TAVI procedures take place while participants wait
- Days alive and out of hospital at 30 days and 12 weeks, total health care costs, and wait times
Researchers will compare usual wait times to see if the tool reduces death, hospitalizations, and urgent procedures.
- Conditions
- Aortic Stenosis
- Being tested
- Triage Tool
- Keywords
- aortic stenosis, TAVI, Trans-catheter Aortic Valve Implantation, cardiovascular disease, Surgical Aortic Valve Replacement
- Medical subject headings
- Aortic Valve Stenosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triage ToolOther
Tool that uses patient characteristics to triage patients for an earlier procedure date vs the standard of care 12 week wait for procedure.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Not described |
| Triage tool | Active comparator | Not described Receives: Other: Triage Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy of using the CAN3T tool in triage compared to standard care, in TAVI patients, including: reduce wait-time adverse events, improve patient-centred outcomes, and reduce wait-time health care utilization.
Composite of death, all-cause hospitalization or urgent TAVI (in-hospital and unplanned TAVI) on the TAVI waitlist. The waitlist period is defined as period between TAVI referral and first of either death, TAVI procedure or off list.
Measured: From the beginning of enrollment and continuing for 32 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study startOct 2024 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Step-Wedged Cluster Randomized
- Masking
- None (open label)
- Enrolment
- 5,060 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551610
- Sponsor's protocol ID
- CTO-4926
- Acronym
- CAN3T
- Status last verified
- Jul 2024
- First submitted
- 9 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No personal information or personal health information is being collected from participants.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Step-Wedged Cluster Randomized Registry-Based Multi-Centre Trial to Compare the Efficacy Between the Canadian TAVI Triage Tool and Standard of Care in TAVI Patients in Ontario, Canada
- ClinicalTrials.gov ID
- NCT06551610
- Acronym / sponsor ID
- CAN3T / CTO-4926
- Conditions
- Aortic Stenosis
- Keywords
- aortic stenosis, TAVI, Trans-catheter Aortic Valve Implantation, cardiovascular disease, Surgical Aortic Valve Replacement
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,060 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this trial is to see if a tool that may reduce wait times will reduce bad outcomes in participants on the TAVI waitlist. The main questions it aims to answer are:
- How many deaths, hospitalizations, or urgent TAVI procedures take place while participants wait
- Days alive and out of hospital at 30 days and 12 weeks, total health care costs, and wait times
Researchers will compare usual wait times to see if the tool reduces death, hospitalizations, and urgent procedures.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Step-Wedged Cluster Randomized
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | – |
| Triage tool | Active comparator | Other: Triage Tool |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients referred for TAVI who are 18 years or older at one of 11 TAVI hospitals
Key exclusion criteria (2 listed)
- Any inpatient referrals who have an urgent inpatient TAVI on the same admission
- Any referral during the 1-month transition period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triage ToolTool that uses patient characteristics to triage patients for an earlier procedure date vs the standard of care 12 week wait for procedure. | Other | Triage tool |
Primary outcome
To assess the efficacy of using the CAN3T tool in triage compared to standard care, in TAVI patients, including: reduce wait-time adverse events, improve patient-centred outcomes, and reduce wait-time health care utilization.
Time frame: From the beginning of enrollment and continuing for 32 months.
Composite of death, all-cause hospitalization or urgent TAVI (in-hospital and unplanned TAVI) on the TAVI waitlist. The waitlist period is defined as period between TAVI referral and first of either death, TAVI procedure or off list.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. No personal information or personal health information is being collected from participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Triage Tool in people with Aortic Stenosis, run by Sunnybrook Health Sciences Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CAN3T Project Manager (416-480-4246, CAN3T@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the efficacy of using the CAN3T tool in triage compared to standard care, in TAVI patients, including: reduce wait-time adverse events, improve patient-centred outcomes, and reduce wait-time health care utilization. (time frame: From the beginning of enrollment and continuing for 32 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.