Multicenter Study Evaluating the Efficacy of an Intervention Aimed At Reducing the Length of Stay After Transfemoral Transcatheter Aortic Valve Implantation

Not Applicable

Completed

• Conditions: Aortic Valve Stenosis; Cardiovascular Diseases
• Interventions: Other: Training

• Registration Number: NCT04503655
• Lead Sponsor: University Hospital, Rouen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-03
• Study First Submitted QC: 2020-08-03
• Study First Posted: 2020-08-07
• Study Start: 2020-12-16
• Primary Completion: 2022-02-09
• Study Completion: 2022-02-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1842

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Training	The randomized centres in this group will be follow a training dedicated on implementation of "organizational" and "therapeutic" measures (for prevention and management of complications) to reduce lenght-of-stay after TF TAVI.

Primary Outcome Measures

Name	Time	Method
To evaluate the effectiveness of a multi-component organizational intervention	Year 1	Proportion of patients benefiting from TF-TAVI with a length of stay less than or equal to 3 days.

Secondary Outcome Measures

Name	Time	Method
To evaluate the implementation of the intervention	Year 1	This outcome will be evaluated using the rate of adherence of the centers to the procedures aiming to reduce the length of stay (questionnaires)
To identify the factors associated with the effectiveness and safety of the intervention	Year 1	This outcome will be assessed using factors associated with lengths of stay less than or equal to 3 days.
To evaluate the safety of the intervention	Day 30	This outcome will be evaluated using : * the average length of stay,; * the 30-day rehospitalization rate and; * the 30-day death rate.
To evaluate the budgetary impact of the intervention	Year 1	This outcome will be assessed using: * the hospital costs from the point of view of the hospital and; * the financial gains for health insurance that would be associated with the generalization of the intervention in France.

Trial Locations

Locations (20)

Hôpital privé Saint Martin; 🇫🇷 Caen, France

Hôpital privé Jacques Cartier; 🇫🇷 Massy, France

Clinique du Millénaire; 🇫🇷 Montpellier, France

CHU de Dijon; 🇫🇷 Dijon, France

CHU de Limoges; 🇫🇷 Limoges, France

CHU de Poitiers; 🇫🇷 Poitiers, France

Clinique Pasteur; 🇫🇷 Toulouse, France

CHU d'Angers; 🇫🇷 Angers, France

CHU de Caen; 🇫🇷 Caen, France

CHU de Grenoble; 🇫🇷 Grenoble, France

CHU d'Amiens; 🇫🇷 Amiens, France

CHU de Brest; 🇫🇷 Brest, France

Hôpital Henri Mondor (AP-HP); 🇫🇷 Créteil, France

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

CHU de Bordeaux; 🇫🇷 Bordeaux, France

Hôpital Bichat, AP-HP; 🇫🇷 Paris, France

Hôpital Européen Georges Pompidou (AP-HP); 🇫🇷 Paris, France

CHU de Strasbourg; 🇫🇷 Strasbourg, France

CHU de Toulouse; 🇫🇷 Toulouse, France

Clinique Saint Gatien; 🇫🇷 Tours, France