Multicenter Study Evaluating the Efficacy of an Intervention Aimed At Reducing the Length of Stay After Transfemoral Transcatheter Aortic Valve Implantation (FAST-TAVI II)

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Aortic Valve Stenosis
• Intervention / Treatment: Other: Training

• Study Type: Interventional
• Enrollment (Actual): 1842
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; The randomized centres in this group will not change their practices.
Experimental: Intervention group; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2020
• Primary Completion (Actual): February 9, 2022
• Study Completion (Actual): February 9, 2022

Study Registration Dates

• First Submitted: August 3, 2020
• First Submitted That Met QC Criteria: August 3, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Actual): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Aortic valve stenosis; TAVI; Medico-economy; Lenght-of-stay
• Additional Relevant MeSH Terms: Aortic Valve Disease; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Cardiovascular Diseases
• Other Study ID Numbers: 2020/0185/HP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No