Aortic Valve StenosisFAST-TAVI IINCT04503655
Multicenter Study Evaluating the Efficacy of an Intervention Aimed At Reducing the Length of Stay After Transfemoral Transcatheter Aortic Valve Implantation
A study testing Training in people with Aortic Valve Stenosis and Cardiovascular Diseases, run by University Hospital, Rouen at 20 sites in France.
Trial 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) . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Cardiovascular Diseases
- What is being tested?
- Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,842 participants
- Where
- 20 sitesFrance
- Study dates
- 16 Dec 2020to 9 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
France20 sites
CHU d'Amiens
Amiens
CHU d'Angers
Angers
CHU de Bordeaux
Bordeaux
CHU de Brest
Brest
CHU de Caen
Caen
Hôpital privé Saint Martin
Caen
CHU de Clermont-Ferrand
Clermont-Ferrand
Hôpital Henri Mondor (AP-HP)
Créteil
CHU de Dijon
Dijon
CHU de Grenoble
Grenoble
CHU de Limoges
Limoges
Hôpital privé Jacques Cartier
Massy
Clinique du Millénaire
Montpellier
Hôpital Bichat, AP-HP
Paris
Hôpital Européen Georges Pompidou (AP-HP)
Paris
CHU de Poitiers
Poitiers
CHU de Strasbourg
Strasbourg
CHU de Toulouse
Toulouse
Clinique Pasteur
Toulouse
Clinique Saint Gatien
Tours
About this study
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
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.
- Conditions
- Aortic Valve Stenosis, Cardiovascular Diseases
- Being tested
- Training
- Keywords
- TAVI, Aortic valve stenosis, Lenght-of-stay, Medico-economy
- Medical subject headings
- Aortic Valve Stenosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
Training dedicated on implementation of "organizational" and "therapeutic" measures (for prevention and management of complications) to reduce lenght-of-stay after TF TAVI.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Other: Training |
| Control group | No intervention | The randomized centres in this group will not change their practices. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Year 1
Secondary outcomes (4)
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.
Measured: Day 30
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.
Measured: Year 1
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)
Measured: Year 1
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.
Measured: Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start16 Dec 2020
- Primary completion9 Feb 2022
- Study completion9 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this study, there is a randomization of the participating centres in two groups.
- Masking
- None (open label)
- Enrolment
- 1,842 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503655
- Sponsor's protocol ID
- 2020/0185/HP
- Acronym
- FAST-TAVI II
- Status last verified
- Dec 2024
- First submitted
- 3 Aug 2020
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38437633
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04503655
- Acronym / sponsor ID
- FAST-TAVI II / 2020/0185/HP
- Conditions
- Aortic Valve Stenosis, Cardiovascular Diseases
- Keywords
- TAVI, Aortic valve stenosis, Lenght-of-stay, Medico-economy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,842 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 9 Feb 2022 (actual)
- Study completion
- 9 Feb 2022 (actual)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this study, there is a randomization of the participating centres in two groups.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: TrainingThe 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 intervention | –The randomized centres in this group will not change their practices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrainingTraining dedicated on implementation of "organizational" and "therapeutic" measures (for prevention and management of complications) to reduce lenght-of-stay after TF TAVI. | Other | Intervention group |
Primary outcome
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.
4 secondary outcomes
To evaluate the safety of the intervention
Time frame: Day 30
To evaluate the budgetary impact of the intervention
Time frame: Year 1
To evaluate the implementation of the intervention
Time frame: Year 1
To identify the factors associated with the effectiveness and safety of the intervention
Time frame: Year 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Derived from this study: PubMed 38437633Durand 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Aortic Valve Stenosis and Cardiovascular Diseases, run by University Hospital, Rouen at 20 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effectiveness of a multi-component organizational intervention (time frame: Year 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04503655, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.