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Evaluation of Length of Stay After TF-TAVI (FAST-TAVI)

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ClinicalTrials.gov Identifier: NCT02956915
Recruitment Status : Completed
First Posted : November 7, 2016
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Brief 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 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.


Condition or disease Intervention/treatment
Severe Symptomatic Aortic Stenosis Procedure: Transfemoral Transcatheter aortic valve implantation

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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : May 22, 2017
Actual Primary Completion Date : February 23, 2018
Actual Study Completion Date : February 23, 2018


Group/Cohort Intervention/treatment
patients with severe symptomatic aortic stenosis
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.
Procedure: Transfemoral Transcatheter aortic valve implantation
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.




Primary Outcome Measures :
  1. Evaluation of length of stay and reasons for prolonged hospitalization beyond 3 days [ Time Frame: 30 days after TF TAVI procedure ]

Secondary Outcome Measures :
  1. Incidence of early discharge/prolonged hospitalization in the overall study population [ Time Frame: 30 days after TF TAVI procedure ]
    Length of stay will be calculated from TAVI procedure (day 0) to discharge

  2. Safety of early discharge [ Time Frame: 30 days after TF TAVI procedure ]
    Combined endpoint of mortality or rehospitalization at 30-days after TF-TAVI procedure

  3. Predictors of early discharge success or failure by multivariate analysis [ Time Frame: 30 days after TF TAVI procedure ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients undergoing an elective TF-TAVI procedure with a SAPIEN-3 prosthesis at participating centers
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956915


Locations
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France
Brest University Hospital
Brest, France
Jacques Cartier Private Hospital
Massy, France
AP-HP Bichat - Claude Bernard Hospital
Paris, France
Rennes University Hospital
Rennes, France
Rouen University Hospital
Rouen, France
Sponsors and Collaborators
University Hospital, Rouen
Investigators
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Principal Investigator: Hélène ELTCHANINOFF, Pr Rouen University Hospital

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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT02956915     History of Changes
Other Study ID Numbers: 2016/012/HP
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Rouen:
Transcatheter aortic valve implantation
SAPIEN-3 prostheses
Length of stay
Aortic stenosis
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction