Severe Symptomatic Aortic StenosisFAST-TAVINCT02956915
Evaluation of Length of Stay After TF-TAVI
A study testing Transfemoral Transcatheter aortic valve implantation in people with Severe Symptomatic Aortic Stenosis, run by University Hospital, Rouen at 5 sites in France.
Trial summary
Transcatheter aortic valve implantation (TAVI) has been rapidly adopted worldwide since the first-in-man TAVI performed in 2002. With increasing experience and improvements in valve design, the "minimalist" approach to transfemoral TAVI (using local anesthesia and fluoroscopic guidance) has become an attractive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Symptomatic Aortic Stenosis
- What is being tested?
- Transfemoral Transcatheter aortic valve implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 5 sitesFrance
- Study dates
- 22 May 2017to 23 Feb 2018
- 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
- Stable patients with severe symptomatic aortic stenosis
- Patient undergoing planned TF-TAVI with the SAPIEN-3 prosthesis,
- TF-TAVI using a minimalist approach of local anesthesia and conscious sedation
Who cannot join
- The use of other (than Edwards SAPIEN-3 or XT) transcatheter aortic valve devices.
- TF-TAVI requiring general anesthesia or surgical cut-down.
- TF-TAVI performed in unstable patients or on an urgent/emergent basis.
- Non-transfemoral routes of valve delivery (eg. transapical, transaortic, etc).
- Discharge back home impossible (including transfer in another hospital)
- Programmed transfer to another hospital
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Brest University Hospital
Brest
Jacques Cartier Private Hospital
Massy
AP-HP Bichat - Claude Bernard Hospital
Paris
Rennes University Hospital
Rennes
Rouen University Hospital
Rouen
About this study
Official title: Evaluation of Length of Stay and Predisposing Factors of Late Discharge After Transfemoral Transcatheter Aortic Valve Implantation Using the SAPIEN-3 Prosthesis: A French Multicenter Prospective Observational Trial
Transcatheter aortic valve implantation (TAVI) has been rapidly adopted worldwide since the first-in-man TAVI performed in 2002. With increasing experience and improvements in valve design, the "minimalist" approach to transfemoral TAVI (using local anesthesia and fluoroscopic guidance) has become an attractive concept, and the technical feasibility of this approach has been well documented.
While earlier data showed prolonged length of stay after TF-TAVI [10.5 ± 8.1 days in the FRANCE 2 registry and 10.2 ± 11.1 days in the PARTNER Cohort A data, the UK TAVI registry (reference) showed a decline in post-TAVI length of stay from 10 days to 8 days over the time period of 2007 to 2012. More contemporary data from other centers has been published showing that 23% of TF-TAVI patients were discharged within 3 days after TAVI. With an increasingly minimalist approach to TF-TAVI, the duration of monitoring required post-procedure remains indeterminate with a lack of formal consensus.
Early discharge (within 3 days of TAVI) is hypothesized to have multiple potential advantages, including reduction in unnecessarily lengthy hospitalization of frail and elderly patients in addition to cost-saving benefits. Rouen University Hospital has previously published a retrospective study on the feasibility and safety of early discharge, in which discharge within 72 hours of uncomplicated TF-TAVI was safe and attained in 36% of our patients. Pre-existing pacemaker and the absence of acute kidney injury were independent predictors of a successful early discharge. Moreover, in a prospective study, Rouen University Hospital recently shown that early discharge afterelective TF-TAVI with SAPIEN-XT/SAPIEN-3 prostheses was attainable in a large proportion of patients (59%) with no evident compromise in safety. Factors associated with failure of early discharge were postprocedural blood transfusion and permanent pacemaker implantation. But currently, there are no guidelines for the length of stay after a TF-TAVI.
- Conditions
- Severe Symptomatic Aortic Stenosis
- Being tested
- Transfemoral Transcatheter aortic valve implantation
- Keywords
- Transcatheter aortic valve implantation, SAPIEN-3 prostheses, Length of stay, Aortic stenosis
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transfemoral Transcatheter aortic valve implantationProcedure or surgery
Transcatheter aortic valve implantation (TAVI): The SAPIEN-3 prosthese are implanted without open heart surgery. The valve delivery system is inserted in the body via the femoral artery.
| Study group | Role | What they receive |
|---|---|---|
| patients with severe symptomatic aortic stenosis | Experimental | Stable patients with severe symptomatic aortic stenosis undergoing planned Transfemoral Transcatheter aortic valve implantation with the SAPIEN-3 prosthesis will be included. TF-TAVI will be done using a minimalist approach of local anesthesia and conscious sedation. Receives: Procedure: Transfemoral Transcatheter aortic valve implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of length of stay and reasons for prolonged hospitalization beyond 3 days
Measured: 30 days after TF TAVI procedure
Secondary outcomes (3)
Incidence of early discharge/prolonged hospitalization in the overall study population
Length of stay will be calculated from TAVI procedure (day 0) to discharge
Measured: 30 days after TF TAVI procedure
Safety of early discharge
Combined endpoint of mortality or rehospitalization at 30-days after TF-TAVI procedure
Measured: 30 days after TF TAVI procedure
Predictors of early discharge success or failure by multivariate analysis
Measured: 30 days after TF TAVI procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study start22 May 2017
- Primary completion23 Feb 2018
- Study completion23 Feb 2018
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 Severe Symptomatic Aortic 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène ELTCHANINOFF, Pr, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956915
- Sponsor's protocol ID
- 2016/012/HP
- Acronym
- FAST-TAVI
- Status last verified
- Apr 2026
- First submitted
- 3 Nov 2016
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Durand E, Le Breton H, Lefevre T, Gilard M, Himbert D, Alcazar MU, Bettinger N, Auffret V, Didier R, Chevalier B, Beziau DM, Iung B, Eltchaninoff H. Evaluation of length of stay after transfemoral transcatheter aortic valve implantation with SAPIEN 3 prosthesis: A French multicentre prospective observational trial. Arch Cardiovasc Dis. 2020 Jun-Jul;113(6-7):391-400. doi: 10.1016/j.acvd.2019.11.010. Epub 2020 May 14.
PubMed 32418883
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Length of Stay and Predisposing Factors of Late Discharge After Transfemoral Transcatheter Aortic Valve Implantation Using the SAPIEN-3 Prosthesis: A French Multicenter Prospective Observational Trial
- ClinicalTrials.gov ID
- NCT02956915
- Acronym / sponsor ID
- FAST-TAVI / 2016/012/HP
- Conditions
- Severe Symptomatic Aortic Stenosis
- Keywords
- Transcatheter aortic valve implantation, SAPIEN-3 prostheses, Length of stay, Aortic stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 22 May 2017 (actual)
- Primary completion
- 23 Feb 2018 (actual)
- Study completion
- 23 Feb 2018 (actual)
- First posted
- 7 Nov 2016 (estimated)
- 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.
Transcatheter aortic valve implantation (TAVI) has been rapidly adopted worldwide since the first-in-man TAVI performed in 2002. With increasing experience and improvements in valve design, the "minimalist" approach to transfemoral TAVI (using local anesthesia and fluoroscopic guidance) has become an attractive concept, and the technical feasibility of this approach has been well documented.
While earlier data showed prolonged length of stay after TF-TAVI [10.5 ± 8.1 days in the FRANCE 2 registry and 10.2 ± 11.1 days in the PARTNER Cohort A data, the UK TAVI registry (reference) showed a decline in post-TAVI length of stay from 10 days to 8 days over the time period of 2007 to 2012. More contemporary data from other centers has been published showing that 23% of TF-TAVI patients were discharged within 3 days after TAVI. With an increasingly minimalist approach to TF-TAVI, the duration of monitoring required post-procedure remains indeterminate with a lack of formal consensus.
Early discharge (within 3 days of TAVI) is hypothesized to have multiple potential advantages, including reduction in unnecessarily lengthy hospitalization of frail and elderly patients in addition to cost-saving benefits. Rouen University Hospital has previously published a retrospective study on the feasibility and safety of early discharge, in which discharge within 72 hours of uncomplicated TF-TAVI was safe and attained in 36% of our patients. Pre-existing pacemaker and the absence of acute kidney injury were independent predictors of a successful early discharge. Moreover, in a prospective study, Rouen University Hospital recently shown that early discharge afterelective TF-TAVI with SAPIEN-XT/SAPIEN-3 prostheses was attainable in a large proportion of patients (59%) with no evident compromise in safety. Factors associated with failure of early discharge were postprocedural blood transfusion and permanent pacemaker implantation. But currently, there are no guidelines for the length of stay after a TF-TAVI.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with severe symptomatic aortic stenosis | Experimental | Procedure: Transfemoral Transcatheter aortic valve implantationStable patients with severe symptomatic aortic stenosis undergoing planned Transfemoral Transcatheter aortic valve implantation with the SAPIEN-3 prosthesis will be included. TF-TAVI will be done using a minimalist approach of local anesthesia and conscious sedation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stable patients with severe symptomatic aortic stenosis
- Patient undergoing planned TF-TAVI with the SAPIEN-3 prosthesis,
- TF-TAVI using a minimalist approach of local anesthesia and conscious sedation
Key exclusion criteria (6 listed)
- The use of other (than Edwards SAPIEN-3 or XT) transcatheter aortic valve devices.
- TF-TAVI requiring general anesthesia or surgical cut-down.
- TF-TAVI performed in unstable patients or on an urgent/emergent basis.
- Non-transfemoral routes of valve delivery (eg. transapical, transaortic, etc).
- Discharge back home impossible (including transfer in another hospital)
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 |
|---|---|---|
| Transfemoral Transcatheter aortic valve implantationTranscatheter aortic valve implantation (TAVI): The SAPIEN-3 prosthese are implanted without open heart surgery. The valve delivery system is inserted in the body via the femoral artery. | Procedure or surgery | patients with severe symptomatic aortic stenosis |
Primary outcome
Evaluation of length of stay and reasons for prolonged hospitalization beyond 3 days
Time frame: 30 days after TF TAVI procedure
3 secondary outcomes
Incidence of early discharge/prolonged hospitalization in the overall study population
Time frame: 30 days after TF TAVI procedure
Safety of early discharge
Time frame: 30 days after TF TAVI procedure
Predictors of early discharge success or failure by multivariate analysis
Time frame: 30 days after TF TAVI procedure
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 15 May 2026.
- Results publication: PubMed 32418883Durand E, Le Breton H, Lefevre T, Gilard M, Himbert D, Alcazar MU, Bettinger N, Auffret V, Didier R, Chevalier B, Beziau DM, Iung B, Eltchaninoff H. Evaluation of length of stay after transfemoral transcatheter aortic valve implantation with SAPIEN 3 prosthesis: A French multicentre prospective observational trial. Arch Cardiovasc Dis. 2020 Jun-Jul;113(6-7):391-400. doi: 10.1016/j.acvd.2019.11.010. Epub 2020 May 14.
- Individual participant dataSharing planned: No
Related trials for Severe Symptomatic Aortic Stenosis
RecruitingObservational study
PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)
Active, not recruiting
DurAVR™ THV EU-EFS
Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis
Enrolling by invitation
ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation
Aortic Valve Stenosis, Heart Valve Diseases
Not yet recruiting
Safety and Clinical Performance of the Next-Generation SAFESYNC Transcatheter Heart Valve in Patients With Severe Aortic Stenosis
Aortic Stenosis Senile, Aortic Stenosis Symptomatic
Recruiting
Isolated Surgical Aortic Valve Replacement in Low Risk AS Patients
Aortic Stenosis
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.
Hélène ELTCHANINOFF, Pr principal investigator
University Hospital, Rouen
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transfemoral Transcatheter aortic valve implantation in people with Severe Symptomatic Aortic Stenosis, run by University Hospital, Rouen at 5 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 3 inclusion and 6 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 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Evaluation of length of stay and reasons for prolonged hospitalization beyond 3 days (time frame: 30 days after TF TAVI procedure). 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 NCT02956915, 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 15 May 2026.