Clinical trial NCT04503655: Multicenter Study Evaluating the Efficacy of an Intervention Aimed At Reducing the Length of Stay After Transfemoral Transcatheter Aortic Valve Implantation
Official title: Etude Multicentrique Évaluant L'efficacité D'une Intervention Visant À Réduire La Durée De Séjour Après L'implantation D'une Bioprothèse Aortique Par Voie Transfémorale
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Cardiovascular Diseases
Keywords: TAVI
Aortic valve stenosis
Lenght-of-stay
Medico-economy
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 1842
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, there is a randomization of the participating centres in two groups.
Primary purpose: OTHER

Brief summary: Since the first implantation of a percutaneous aortic bioprosthesis (TAVI) in 2002 (Cribier et al. Circulation 2002), TAVI occupies an increasing place in the management of aortic stenosis (AR) . Initially reserved for inoperable patients at high surgical risk, TAVI is also recommended in patients at intermediate risk, especially when a femoral approach (TF) is possible (Baumgartner et al. Eur Heart J. 2017).

Currently, there is no recommendation regarding length of stay after TAVI and practices are extremely heterogeneous. Despite the growing experience of centers, better patient selection and a reduction in complications, the length of stay after TAVI remains very high in France.

Faced with the great disparity observed between the centers, efforts are necessary to educate the centers in order to further reduce the length of stay after TF-TAVI. The aim of the study is to evaluate the effectiveness of an intervention based on training teams to reduce the length of stay after TF-TAVI.


Eligibility criteria: Inclusion Criteria:

1. Patient over 18 years of age;
2. Patient hospitalized for TF-TAVI
3. Patient affiliated or benefiting from a health insurance scheme
4. Patient having read and understood the information letter and having signed the consent form.

Exclusion Criteria:

1. 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) ; 1
2. Person deprived of their liberty by an administrative or judicial decision or person placed under the protection of justice / guardianship or curatorship
3. 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

Primary outcomes:
measure: To evaluate the effectiveness of a multi-component organizational intervention
timeFrame: Year 1
Secondary outcomes:
measure: To evaluate the safety of the intervention
timeFrame: Day 30
measure: To evaluate the budgetary impact of the intervention
timeFrame: Year 1
measure: To evaluate the implementation of the intervention
timeFrame: Year 1
measure: To identify the factors associated with the effectiveness and safety of the intervention
timeFrame: Year 1
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU d'Amiens
city: Angers
country: France
facility: CHU d'Angers
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Brest
country: France
facility: CHU de Brest
city: Caen
country: France
facility: CHU de Caen
city: Caen
country: France
facility: Hôpital privé Saint Martin
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Créteil
country: France
facility: Hôpital Henri Mondor (AP-HP)
city: Dijon
country: France
facility: CHU de Dijon
city: Grenoble
country: France
facility: CHU de Grenoble
city: Limoges
country: France
facility: CHU de Limoges
city: Massy
country: France
facility: Hôpital privé Jacques Cartier
city: Montpellier
country: France
facility: Clinique du Millénaire
city: Paris
country: France
facility: Hôpital Bichat, AP-HP
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou (AP-HP)
city: Poitiers
country: France
facility: CHU de Poitiers
city: Strasbourg
country: France
facility: CHU de Strasbourg
city: Toulouse
country: France
facility: CHU de Toulouse
city: Toulouse
country: France
facility: Clinique Pasteur
city: Tours
country: France
facility: Clinique Saint Gatien
Study officials:
References: