NCT03865043

Vascular Complications and Bleeding After Transfemoral TAVI

Completed Last updated 10 March 2020

What this trial tests

trial in Severe and Symptomatic Aortic Stenosis in 300 participants. Completed in 31 December 2019.

Timeline

1 February 2019

Primary endpoint
31 December 2019

31 December 2019

Quick facts

Lead sponsor	University Hospital, Montpellier
Status	Completed
Study type	OBSERVATIONAL
Enrollment	300
Start date	1 February 2019
Primary completion	31 December 2019
Estimated completion	31 December 2019
Sites	1 location across France

Conditions studied

• Severe and Symptomatic Aortic Stenosis — all drugs for Severe and Symptomatic Aortic Stenosis →
• Undergoing TAVI — all drugs for Undergoing TAVI →

Sponsor

University Hospital, Montpellier

Who can join

18 and older, any sex, with Severe and Symptomatic Aortic Stenosis or Undergoing TAVI. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.