CAN3T - Canadian TAVI Triage Tool

NCT06551610 | Not Yet Recruiting

• 1 other identifier: CTO-4926
• Study Type: interventional
• Target: 5,060
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Keywords

aortic stenosis; TAVI; Trans-catheter Aortic Valve Implantation; cardiovascular disease; Surgical Aortic Valve Replacement

Outcome Measures

Primary Outcomes (1)

• 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.

  From the beginning of enrollment and continuing for 32 months.

Study Arms (2)

Standard of Care

NO INTERVENTION

Triage tool

ACTIVE COMPARATOR

Other: Triage Tool

Interventions

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.

Triage tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

MeSH Terms

Conditions

Aortic Valve Stenosis; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Ventricular Outflow Obstruction

Central Study Contacts

CAN3T Project Manager

CONTACT

416-480-4246; CAN3T@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Step-Wedged Cluster Randomized

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 13, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share