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

NCT ID: NCT05237804

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 748 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-26
• Study Completion Date: 2025-12-31

Brief 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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control group

The randomized centres in this group will not change their practices.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Patient component

Intervention Type: OTHER

Video, booklet, website

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.

Group Type: EXPERIMENTAL

Organisational component

Intervention Type: OTHER

Coronarography, CT-scan, anesthesia...

Patient and organisational components

The randomized centres in this group will have to implement the two components.

Group Type: EXPERIMENTAL

Patient component

Intervention Type: OTHER

Video, booklet, website

Organisational component

Intervention Type: OTHER

Coronarography, CT-scan, anesthesia...

Interventions

Patient component

Video, booklet, website

Intervention Type: OTHER

Organisational component

Coronarography, CT-scan, anesthesia...

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helene Eltchaninoff, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

Brest University Hospital

Brest, , France

CHU de Rouen

Rouen, , France

Countries

France

Other Identifiers

2021/0226/HP

Identifier Type: -

Identifier Source: org_study_id