Vascular Complications and Bleeding After Transfemoral TAVI

NCT03865043 | Completed

• 1 other identifier: RECHMPL18_0486
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Since the first implantation by Cribier, transcatheter aortic valve implantation (TAVI) revolutionized the management of severe symptomatic aortic stenosis. Indeed, TAVI is indicated as an alternative to conventional surgery in patients at high surgical risk or contra-indicated to conventional surgery. However, TAVI remains associated with specific complications related to the technics itself dominated by vascular complications and conductive disorders. Major vascular complications remain frequent after TAVI despite improvements in operators' experience, patient's selection and lower profile devices. Indeed, according to the Valve Academic Research Consortium 2 (VARC-2) criteria , major VC are still reported with an incidence of 1.5% to 15% of the procedures in registries and may be associated with unfavorable clinical outcomes. Currently, percutaneous approach (PC) in transfemoral TAVI is performed in routine, considered as a less invasive strategy than the traditional surgical cutdown (SC) performed in the first TAVI experience. Indeed, percutaneous approach may facilitate the local anesthesia and does not require the presence of the surgeon in the catheterization laboratory . However, surgical approach is still performed in many centers, allowing a better control of the puncture site with a low rate of vascular complications . Several non-randomized studies compared the two approaches with contradictory results\]. No data are available comparing both approaches performed by the same team during the same period. The aim of this study was to compare percutaneous and surgical approaches in terms of vascular complications and bleeding in patients undergoing transfemoral TAVI.

Conditions

Severe and Symptomatic Aortic Stenosis; Undergoing TAVI

Keywords

TAVI; preclosing

Outcome Measures

Primary Outcomes (1)

• vascular complications and bleeding

  The primary endpoint of our study is a composite of vascular complications and bleeding defined by the modified VARC-2 classification

  1 day (at the end of hospitalization)

Secondary Outcomes (5)

• Other complications after TAVI

  1 day (at the end of hospitalization)

• amount of radiation

  1 day (at the end of hospitalization)

• amount of contrast

  1 day (at the end of hospitalization)

• procedure duration

  1 day (at the end of hospitalization)

• hospitalization length

  1 day (at the end of hospitalization)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

November 2017 at Montpellier University Hospital, France, for severe symptomatic aortic stenosis

You may qualify if:

• Patients undergoing a TAVI at Montpellier University Hospital
• Since November 2017
• With implantation of a COREVALVE or EDWARDS
• By femoral approach

You may not qualify if:

• Minor patient
• Patient unable to give consent for reasons of understanding or language barrier

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Study Officials

• Florence LECLERCQ

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 6, 2019
• Study Start: February 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 10, 2020

Record last verified: 2020-03

Locations

FR (1)