Back to resultsMulticenter Study Evaluating the Efficacy of an Intervention Aimed at Reducing the Length of Stay After Transfemoral Transcatheter Aortic Valve Implantation (FAST-TAVI II)
Primary Purpose
Aortic Valve Stenosis, Cardiovascular Diseases
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Training
Sponsored by
About this trial
This is an interventional other trial for Aortic Valve Stenosis focused on measuring TAVI, Aortic valve stenosis, Lenght-of-stay, Medico-economy
Eligibility Criteria
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
Sites / Locations
- CHU d'Amiens
- CHU d'Angers
- CHU de Bordeaux
- CHU de Brest
- CHU de Caen
- Hôpital privé Saint Martin
- CHU de Clermont-Ferrand
- Hôpital Henri Mondor (AP-HP)
- CHU de Dijon
- CHU de Grenoble
- CHU de Limoges
- Hôpital privé Jacques Cartier
- Clinique du Millénaire
- Hôpital Bichat, AP-HP
- Hôpital Européen Georges Pompidou (AP-HP)
- CHU de Poitiers
- CHU de Strasbourg
- CHU de Toulouse
- Clinique Pasteur
- Clinique Saint Gatien
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm 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.
The randomized centres in this group will not change their practices.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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)
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.
Full Information
NCT ID
NCT04503655
First Posted
August 3, 2020
Last Updated
May 17, 2022
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT04503655
Brief Title
Multicenter Study Evaluating the Efficacy of an Intervention Aimed at Reducing the Length of Stay After Transfemoral Transcatheter Aortic Valve Implantation
Acronym
FAST-TAVI II
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 16, 2020 (Actual)
Primary Completion Date
February 9, 2022 (Actual)
Study Completion Date
February 9, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis, Cardiovascular Diseases
Keywords
TAVI, Aortic valve stenosis, Lenght-of-stay, Medico-economy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In this study, there is a randomization of the participating centres in two groups.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1842 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The randomized centres in this group will not change their practices.
Intervention Type
Other
Intervention Name(s)
Training
Intervention Description
Training dedicated on implementation of "organizational" and "therapeutic" measures (for prevention and management of complications) to reduce lenght-of-stay after TF TAVI.
Primary Outcome Measure Information:
Title
To evaluate the effectiveness of a multi-component organizational intervention
Description
Proportion of patients benefiting from TF-TAVI with a length of stay less than or equal to 3 days.
Time Frame
Year 1
Secondary Outcome Measure Information:
Title
To evaluate the safety of the intervention
Description
This outcome will be evaluated using :
the average length of stay,
the 30-day rehospitalization rate and
the 30-day death rate.
Time Frame
Day 30
Title
To evaluate the budgetary impact of the intervention
Description
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.
Time Frame
Year 1
Title
To evaluate the implementation of the intervention
Description
This outcome will be evaluated using the rate of adherence of the centers to the procedures aiming to reduce the length of stay (questionnaires)
Time Frame
Year 1
Title
To identify the factors associated with the effectiveness and safety of the intervention
Description
This outcome will be assessed using factors associated with lengths of stay less than or equal to 3 days.
Time Frame
Year 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU d'Amiens
City
Amiens
Country
France
Facility Name
CHU d'Angers
City
Angers
Country
France
Facility Name
CHU de Bordeaux
City
Bordeaux
Country
France
Facility Name
CHU de Brest
City
Brest
Country
France
Facility Name
CHU de Caen
City
Caen
Country
France
Facility Name
Hôpital privé Saint Martin
City
Caen
Country
France
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
Country
France
Facility Name
Hôpital Henri Mondor (AP-HP)
City
Créteil
Country
France
Facility Name
CHU de Dijon
City
Dijon
Country
France
Facility Name
CHU de Grenoble
City
Grenoble
Country
France
Facility Name
CHU de Limoges
City
Limoges
Country
France
Facility Name
Hôpital privé Jacques Cartier
City
Massy
Country
France
Facility Name
Clinique du Millénaire
City
Montpellier
Country
France
Facility Name
Hôpital Bichat, AP-HP
City
Paris
Country
France
Facility Name
Hôpital Européen Georges Pompidou (AP-HP)
City
Paris
Country
France
Facility Name
CHU de Poitiers
City
Poitiers
Country
France
Facility Name
CHU de Strasbourg
City
Strasbourg
Country
France
Facility Name
CHU de Toulouse
City
Toulouse
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
Country
France
Facility Name
Clinique Saint Gatien
City
Tours
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Multicenter Study Evaluating the Efficacy of an Intervention Aimed at Reducing the Length of Stay After Transfemoral Transcatheter Aortic Valve Implantation
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