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

Cardiovascular Diseases Clinical Trial

— FAST-TAVI II  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04503655
• Other study ID #: 2020/0185/HP
• Status: Completed
• Phase: N/A
• Start date: December 16, 2020
• Est. completion date: February 9, 2022

Study information

• Verified date: May 2022
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1842
• Est. completion date: February 9, 2022
• Est. primary completion date: February 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Cardiovascular Diseases

Intervention

Other:
• Training
Training dedicated on implementation of "organizational" and "therapeutic" measures (for prevention and management of complications) to reduce lenght-of-stay after TF TAVI.

Locations

Country	Name	City	State
France	CHU d'Amiens	Amiens
France	CHU d'Angers	Angers
France	CHU de Bordeaux	Bordeaux
France	CHU de Brest	Brest
France	CHU de Caen	Caen
France	Hôpital privé Saint Martin	Caen
France	CHU de Clermont-Ferrand	Clermont-Ferrand
France	Hôpital Henri Mondor (AP-HP)	Créteil
France	CHU de Dijon	Dijon
France	CHU de Grenoble	Grenoble
France	CHU de Limoges	Limoges
France	Hôpital privé Jacques Cartier	Massy
France	Clinique du Millénaire	Montpellier
France	Hôpital Bichat, AP-HP	Paris
France	Hôpital Européen Georges Pompidou (AP-HP)	Paris
France	CHU de Poitiers	Poitiers
France	CHU de Strasbourg	Strasbourg
France	CHU de Toulouse	Toulouse
France	Clinique Pasteur	Toulouse
France	Clinique Saint Gatien	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the effectiveness of a multi-component organizational intervention	Proportion of patients benefiting from TF-TAVI with a length of stay less than or equal to 3 days.	Year 1
Secondary	To evaluate the safety of the intervention	This outcome will be evaluated using : the average length of stay,; the 30-day rehospitalization rate and; the 30-day death rate.	Day 30
Secondary	To evaluate the budgetary impact of the intervention	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.	Year 1
Secondary	To evaluate the implementation of the intervention	This outcome will be evaluated using the rate of adherence of the centers to the procedures aiming to reduce the length of stay (questionnaires)	Year 1
Secondary	To identify the factors associated with the effectiveness and safety of the intervention	This outcome will be assessed using factors associated with lengths of stay less than or equal to 3 days.	Year 1