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Completed

NCT Number: NCT02956915

Evaluation of Length of Stay After TF-TAVI

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.

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Key information

Conditions

Severe Symptomatic Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis 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

Brest University Hospital, Brest, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Transfemoral Transcatheter aortic valve implantation

Procedure

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 outcomes

  1. Evaluation of length of stay and reasons for prolonged hospitalization beyond 3 days

    Time frame: 30 days after TF TAVI procedure

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study 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

Acronym: FAST-TAVI

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 7, 2016
Registry last updated
May 15, 2026

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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