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

NCT05237804 | Completed

• 1 other identifier: 2021/0226/HP
• Study Type: interventional
• Target: 828
• Locations: 1 country
• Sites: 2

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

Keywords

Aortic Stenosis; Treatment time; Medico-economy

Outcome Measures

Primary Outcomes (1)

• 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

  Month 6

Secondary Outcomes (13)

• Time to care, in days

  Month 6

• Mortality rate

  Months 3 and 6

• Patients' health-related quality of life

  Baseline, Months 3 and 6

• Patient knowledge of the disease and the TAVI procedure

  Baseline, Month 3

• Medication compliance

  Month 6

Study Arms (4)

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.

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.

Other: Organisational component

Patient and organisational components

EXPERIMENTAL

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

Other: Patient component; Other: Organisational component

Interventions

Organisational component OTHER

Coronarography, CT-scan, anesthesia...

Organisational component; Patient and organisational components

Patient component OTHER

Video, booklet, website

Patient and organisational components; Patient component

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (2)

Brest University Hospital

Brest, France

Location

CHU de Rouen

Rouen, France

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Helene Eltchaninoff, Pr

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: In this study, there is a randomization of the participating centres in 4 groups.

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: February 14, 2022
• Study Start: October 26, 2022
• Primary Completion: October 25, 2024
• Study Completion: October 23, 2025
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

FR (2)