Evaluation of an Intervention to Reduce the Time to Treatment for TAVI Patients (TREAT)

February 17, 2026 updated by: University Hospital, Rouen

Evaluation d'Une Intervention Pour Reduire le Delai de Traitement Des Patients Traites Par TAVI

Aortic stenosis (AS) is the most frequent valvulopathy in Western countries. The prevalence of AS is constantly increasing due to the aging of the population. Although significant progress has been made in understanding the pathophysiological mechanisms underlying the onset and progression of AS, there is no medical treatment to slow or prevent its progression. The only treatment available is Aortic Valve Replacement (AVR) performed by surgery or by catheterization (TAVI).

Once a diagnosis has been made and the decision to treat these patients has been taken, the procedure (AVR or TAVI) must be performed rapidly given the poor prognosis of the disease without treatment. Studies have shown that on the waiting list, the probability of death and hospitalisation for heart failure increases with time. This delay could also reduce the effectiveness of TAVI, thus affecting the performance of the healthcare system.

In this study, an intervention combining an e-health component (tool intended for patients, families and health professionals in contact with patients), and an organisational component (for TAVI implanting centres) has been designed. The aim of this study is to evaluate the effectiveness of this intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
828

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Brest, France
        • Brest University Hospital
      • Rouen, France
        • CHU de Rouen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient over 18 years of age;
  • Aortic stenosis
  • Indication of TAVI
  • Patient affiliated or benefiting from a health insurance scheme
  • Patient having read and understood the information letter and having signed the consent form

Exclusion Criteria:

  • TAVI indication not retained
  • Patient who are not fluent in French and have no one around them to translate,
  • Patient who do not have access to the Internet (at home or in their immediate environment)
  • Proven pregnant woman (positive urine pregnancy test) or breastfeeding or absence of effective contraception (as defined by the WHO) or postmenopausal woman without confirmation diagnosis obtained (amenorrhea not medically induced for at least 12 months before the initiation visit) ;
  • Person deprived of their liberty by an administrative or judicial decision or person placed under the protection of justice / guardianship or curators
  • History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participating in the protocol or preventing him from giving his informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
The randomized centres in this group will not change their practices.
Experimental: Patient component

The randomized centres in this group will be required to present patients with:

  • A short introductory video, viewed on a tablet during hospitalization for coronary angiography,
  • A paper booklet,
  • A website.
Other: Patient component
Video, booklet, website
Experimental: Organisational component
The randomized centres in this group will be provided with a list of organisational changes to be implemented to improve patient care times.
Other: Organisational component
Coronarography, CT-scan, anesthesia...
Experimental: Patient and organisational components
The randomized centres in this group will have to implement the two components.
Other: Patient component
Video, booklet, website
Other: Organisational component
Coronarography, CT-scan, anesthesia...

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To evaluate the effectiveness of an intervention combining a patient component and an organisational component
Time Frame: Month 6
Percentage of patients with a TAVI indication with a time to TAVI procedure of less than 2 months
Month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to care, in days
Time Frame: Month 6
The time to care is the number of days between the date of the initial consultation during which a TAVI is proposed and the date of the TAVI procedure
Month 6
Mortality rate
Time Frame: Months 3 and 6
The mortality rate will be measured between the initial consultation during which a TAVI is proposed and the TAVI procedure, and in the three months following the procedure
Months 3 and 6
Patients' health-related quality of life
Time Frame: Baseline, Months 3 and 6
Patients' health-related quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L).
Baseline, Months 3 and 6
Patient knowledge of the disease and the TAVI procedure
Time Frame: Baseline, Month 3
Patients' knowledge of the disease and the TAVI procedure will be measured by their score to an ad hoc questionnaire (0: minimum score - 26: maximum score).
Baseline, Month 3
Medication compliance
Time Frame: Month 6
Patient medication compliance will be measured using a questionnaire developed by Girerd et al, with a score going from 0 (lowest compliance) to 6 (maximum compliance).
Month 6
Patient satisfaction
Time Frame: Month 6
Patient satisfaction with the care they received and (for the group receiving the patient component) with the patient component of the intervention will be measured using a 0 to 10 Likert scale
Month 6
Number of visits to the patient section of the website
Time Frame: Month 6
The number of visits to the website will be assessed through Googleanalytics®
Month 6
Number of visits to the professional section of the website
Time Frame: Month 6
The number of visits to the website will be assessed through Googleanalytics®
Month 6
Acceptability of the intervention for participating centers
Time Frame: Month 6
The acceptability of the intervention will be assessed through an ad hoc questionnaire addressed to TAVI centers and peripheral hospitals performing the coronary angiography of the pre-TAVI assessment.
Month 6
Intervention components' dose and fidelity
Time Frame: Month 6
Number of different activities really performed for each component of the intervention / number of activities planned for each component according to the protocol.
Month 6
Reached populations
Time Frame: Month 6
Percentage of target individuals who benefit from activities of each component of the intervention
Month 6
Intervention components' adaptation
Time Frame: Month 6
Number of activities performed which have been modified to adapt them to the local context / total number of activities performed. A description of the adaptations performed will be provided.
Month 6
Incremental cost-effectiveness ratio
Time Frame: Month 6
The incremental cost-effectiveness ratio will be expressed in cost per quality-adjusted life-year (QALY) gained, derived from the EQ-5D-5L questionnaire
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Rouen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hélène ELTCHANINOFF, Pr, University Hospital, Rouen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 26, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 25, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 23, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021/0226/HP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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