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Completed

NCT Number: NCT04503655

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

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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU d'Amiens, Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Training

Other

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

Primary outcomes

  1. To evaluate the effectiveness of a multi-component organizational intervention

    Time frame: Year 1

    Proportion of patients benefiting from TF-TAVI with a length of stay less than or equal to 3 days.

Secondary outcomes

  1. To evaluate the safety of the intervention

    Time frame: Day 30

    This outcome will be evaluated using :

    • the average length of stay,
    • the 30-day rehospitalization rate and
    • the 30-day death rate.

  2. To evaluate the budgetary impact of the intervention

    Time frame: Year 1

    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.

  3. To evaluate the implementation of the intervention

    Time frame: Year 1

    This outcome will be evaluated using the rate of adherence of the centers to the procedures aiming to reduce the length of stay (questionnaires)

  4. To identify the factors associated with the effectiveness and safety of the intervention

    Time frame: Year 1

    This outcome will be assessed using factors associated with lengths of stay less than or equal to 3 days.

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study 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

Acronym: FAST-TAVI II

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 7, 2020
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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