Evaluation of an Intervention to Reduce the Time to Treatment for TAVI Patients
Key facts
- Who runs it
- University Hospital, Rouen
- Where
- France2 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 828 people enrolled
- Started
- 26 Oct 2022
- Ended
- 23 Oct 2025
- Type of study
- Interventional, 4 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Patient component
- Organisational component
- Record updated
- 6 November 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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 take part
- 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)
- 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
- 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)
- Person deprived of their liberty by an administrative or judicial decision or person placed under the protection of justice / guardianship or curators
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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).
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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.
The 4 groups in the trial
- Control groupNo study treatment, for comparison
The randomized centres in this group will not change their practices.
- Patient componentTreatment being tested
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.
- Organisational componentTreatment being tested
The 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 componentsTreatment being tested
The randomized centres in this group will have to implement the two components.
Treatment: Patient component and Organisational component
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluation d'Une Intervention Pour Reduire le Delai de Traitement Des Patients Traites Par TAVI
- Record updated
- 6 November 2026