Aortic Valve StenosisTREATNCT05237804
Evaluation of an Intervention to Reduce the Time to Treatment for TAVI Patients
A study testing Patient component and Organisational component in people with Aortic Valve Stenosis, run by University Hospital, Rouen at 2 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Patient component and Organisational component
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 828 participants
- Where
- 2 sitesFrance
- Study dates
- 26 Oct 2022to 23 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Patient component, Organisational component
- Keywords
- Aortic Stenosis, Treatment time, Medico-economy
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient componentOther
Video, booklet, website
Organisational componentOther
Coronarography, CT-scan, anesthesia...
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The randomized centres in this group will not change their practices. |
| Patient component | Experimental | 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. Receives: Other: Patient component |
| Organisational component | Experimental | The randomized centres in this group will be provided with a list of organisational changes to be implemented to improve patient care times. Receives: Other: Organisational component |
| Patient and organisational components | Experimental | The randomized centres in this group will have to implement the two components. Receives: Other: Patient component; Other: Organisational component |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effectiveness of an intervention combining a patient component and an organisational component
Percentage of patients with a TAVI indication with a time to TAVI procedure of less than 2 months
Measured: Month 6
Secondary outcomes (13)
Time to care, in days
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
Measured: Month 6
Mortality rate
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
Measured: Months 3 and 6
Patients' health-related quality of life
Patients' health-related quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L).
Measured: Baseline, Months 3 and 6
Patient knowledge of the disease and the TAVI procedure
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).
Measured: Baseline, Month 3
Medication compliance
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).
Measured: Month 6
Patient satisfaction
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
Measured: Month 6
Number of visits to the patient section of the website
The number of visits to the website will be assessed through Googleanalytics®
Measured: Month 6
Number of visits to the professional section of the website
The number of visits to the website will be assessed through Googleanalytics®
Measured: Month 6
Acceptability of the intervention for participating centers
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.
Measured: Month 6
Intervention components' dose and fidelity
Number of different activities really performed for each component of the intervention / number of activities planned for each component according to the protocol.
Measured: Month 6
Reached populations
Percentage of target individuals who benefit from activities of each component of the intervention
Measured: Month 6
Intervention components' adaptation
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.
Measured: Month 6
Incremental cost-effectiveness ratio
The incremental cost-effectiveness ratio will be expressed in cost per quality-adjusted life-year (QALY) gained, derived from the EQ-5D-5L questionnaire
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start26 Oct 2022
- Primary completion23 Oct 2025
- Study completion23 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this study, there is a randomization of the participating centres in 4 groups.
- Masking
- None (open label)
- Enrolment
- 828 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helene Eltchaninoff, Pr, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237804
- Sponsor's protocol ID
- 2021/0226/HP
- Acronym
- TREAT
- Status last verified
- Feb 2026
- First submitted
- 23 Dec 2021
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation d'Une Intervention Pour Reduire le Delai de Traitement Des Patients Traites Par TAVI
- ClinicalTrials.gov ID
- NCT05237804
- Acronym / sponsor ID
- TREAT / 2021/0226/HP
- Conditions
- Aortic Valve Stenosis
- Keywords
- Aortic Stenosis, Treatment time, Medico-economy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 828 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 23 Oct 2025 (actual)
- Study completion
- 23 Oct 2025 (actual)
- First posted
- 14 Feb 2022 (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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- In this study, there is a randomization of the participating centres in 4 groups.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The randomized centres in this group will not change their practices. |
| Patient component | Experimental | Other: Patient componentThe 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. |
| Organisational component | Experimental | Other: Organisational componentThe randomized centres in this group will be provided with a list of organisational changes to be implemented to improve patient care times. |
| Patient and organisational components | Experimental | Other: Patient component, Other: Organisational componentThe randomized centres in this group will have to implement the two components. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Patient componentVideo, booklet, website | Other | Patient and organisational components, Patient component |
| Organisational componentCoronarography, CT-scan, anesthesia... | Other | Organisational component, Patient and organisational components |
Primary outcome
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
13 secondary outcomes
Time to care, in days
Time frame: Month 6
Mortality rate
Time frame: Months 3 and 6
Patients' health-related quality of life
Time frame: Baseline, Months 3 and 6
Patient knowledge of the disease and the TAVI procedure
Time frame: Baseline, Month 3
Medication compliance
Time frame: Month 6
Patient satisfaction
Time frame: Month 6
Number of visits to the patient section of the website
Time frame: Month 6
Number of visits to the professional section of the website
Time frame: Month 6
Acceptability of the intervention for participating centers
Time frame: Month 6
Intervention components' dose and fidelity
Time frame: Month 6
Reached populations
Time frame: Month 6
Intervention components' adaptation
Time frame: Month 6
Incremental cost-effectiveness ratio
Time frame: Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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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. This study is not recruiting at the moment.
Helene Eltchaninoff, Pr principal investigator
University Hospital, Rouen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient component and Organisational component in people with Aortic Valve Stenosis, run by University Hospital, Rouen at 2 sites in France.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effectiveness of an intervention combining a patient component and an organisational component (time frame: Month 6). 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 6 Nov 2026.