Brief Title
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
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.
Study Type
Interventional
Primary Outcome
To evaluate the effectiveness of a multi-component organizational intervention
Secondary Outcome
To evaluate the safety of the intervention
Condition
Aortic Valve Stenosis
Intervention
Training
Study Arms / Comparison Groups
Intervention group
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
2000
Start Date
November 1, 2020
Completion Date
December 31, 2020
Primary Completion Date
December 1, 2020
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, +33 2 32 88 54 07, [email protected]
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT04503655
Organization ID
2020/0185/HP
Responsible Party
Sponsor
Study Sponsor
University Hospital, Rouen
Study Sponsor
, ,
Verification Date
August 2020