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

University Hospital, Rouen

Status: Completed

Conditions: Aortic Valve Stenosis; Cardiovascular Diseases

Treatments: Other: Training

Study type: Interventional

Funder types: Other

Identifiers

NCT04503655

2020/0185/HP

Details and patient eligibility

About

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.

Enrollment: 1,842 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,842 participants in 2 patient groups

Intervention group

Experimental 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.

Treatment:

Other: Training

Control group

No Intervention group

Description:

The randomized centres in this group will not change their practices.