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
1 other identifier
interventional
1,842
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2020
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2020
CompletedFirst Posted
Study publicly available on registry
August 7, 2020
CompletedStudy Start
First participant enrolled
December 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 9, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 9, 2022
CompletedDecember 9, 2024
December 1, 2024
1.2 years
August 3, 2020
December 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
To evaluate the safety of the intervention
Day 30
To evaluate the budgetary impact of the intervention
Year 1
To evaluate the implementation of the intervention
Year 1
To identify the factors associated with the effectiveness and safety of the intervention
Year 1
Study Arms (2)
Intervention group
EXPERIMENTALThe 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.
Control group
NO INTERVENTIONThe randomized centres in this group will not change their practices.
Interventions
Training dedicated on implementation of "organizational" and "therapeutic" measures (for prevention and management of complications) to reduce lenght-of-stay after TF TAVI.
Eligibility Criteria
You may qualify if:
- Patient over 18 years of age;
- Patient hospitalized for TF-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:
- 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
- Person deprived of their liberty by an administrative or judicial decision or person placed under the protection of justice / guardianship or curatorship
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
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, France
Related Publications (1)
Durand E, Beziau-Gasnier D, Michel M, Iung B, Tchetche D, Bonnet G, Lhermusier T, Gilard M, Souteyrand G, Bouleti C, Ohlmann P, Lefevre T, Beygui F, Chassaing S, Chevreul K, Eltchaninoff H; FAST-TAVI II; STOP-AS investigators. Reducing length of stay after transfemoral transcatheter aortic valve implantation: the FAST-TAVI II trial. Eur Heart J. 2024 Mar 14;45(11):952-962. doi: 10.1093/eurheartj/ehae081.
PMID: 38437633DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2020
First Posted
August 7, 2020
Study Start
December 16, 2020
Primary Completion
February 9, 2022
Study Completion
February 9, 2022
Last Updated
December 9, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share