CAN3T - Canadian TAVI Triage Tool

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.

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Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients referred for TAVI who are 18 years or older at one of 11 TAVI hospitals

Exclusion criteria

Any inpatient referrals who have an urgent inpatient TAVI on the same admission
Any referral during the 1-month transition period

Treatment and study plan

Triage Tool

Other

Tool that uses patient characteristics to triage patients for an earlier procedure date vs the standard of care 12 week wait for procedure.

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

CAN3T Project Manager

CONTACT

[email protected]

416-480-4246

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study 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

Acronym: CAN3T

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2027
First posted: Aug 13, 2024
Registry last updated: Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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