NCT04350658

Brief Summary

The procedure is performed via transfemoral or transcaprotid access; Patients were confirmed to be eligible for TAVR by a multidisciplinary heart team including at least an interventional cardiologist, a cardiothoracic surgeon and an anesthetist. All TAVR implantation procedures were performed with the Edwards SAPIEN 3 THV or the MEDTRONIC CoreValve EVOLUT . For all patients, both vascular access and aortic valve were evaluated before the procedure by multislice computerized tomographic angiography (MSCT) of the entire aorta using vascular windows settings. The prosthesis and the vascular access were left to the discretion of the operating team. Transfemoral access was the first choice when possible. All TAVR procedures were performed in the same hybrid room (in Montpellier University Hospital), Most TAVR were performed under sedation or general anesthesia using mild low profile 14-16 French delivery systems and using percutaneous or surgical vascular access.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

November 11, 2021

Status Verified

November 1, 2021

Enrollment Period

1.1 years

First QC Date

April 15, 2020

Last Update Submit

November 10, 2021

Conditions

Aortic Stenosis

Keywords

TAVRBalloon prediltationsuccess of crossing the valvedirect implanation

Outcome Measures

Primary Outcomes (1)

  • success of the direct implantation

    success of the direct implantation defined as failure of crossing with the THV after 3 attemps and absence of complication related to the direct crossing

    1 day

Secondary Outcomes (3)

  • Indidence of post dilatation

    1 day

  • Underexpansion of the Edwards SAPIEN 3 THV

    1 day

  • risks factors of failure of crossing

    1 day

Study Arms (1)

TAVR

all comers study including all transfemoral or transcarotid TAVR procédures. direct implantation is the default strategy usually used in our enter as in may centers

Procedure: Transcatheter aortic valve implantation required for symptomatic aortic stenosis

Interventions

Transcatheter aortic valve implantation required for symptomatic aortic stenosisPROCEDURE

The procedure is performed via transfemoral or transcarotid access; Patients were confirmed to be eligible for TAVR by a multidisciplinary heart team including at least an interventional cardiologist, a cardiothoracic surgeon and an anesthetist. All TAVR implantation procedures were performed with the Edwards SAPIEN 3 THV or the MEDTRONIC CoreValve EVOLUT . For all patients, both vascular access and aortic valve were evaluated before the procedure by multislice computerized tomographic angiography (MSCT) of the entire aorta using vascular windows settings. The prosthesis and the vascular access were left to the discretion of the operating team. Transfemoral access was the first choice when possible. All TAVR procedures were performed in the same hybrid room (in Montpellier University Hospital), Most TAVR were performed under sedation or general anesthesia using mild low profile 14-16 French delivery systems and using percutaneous or surgical vascular access.

TAVR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all comers patients undergoing TAVR using transfemoral or transcaorotid approaches

You may qualify if:

  • \- patients undergoing TAVR via transfemoral or rascoarotid access

You may not qualify if:

  • \- others access (subclavian, apical, transaortic)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Florence Leclercq, MD, PhD

    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

April 15, 2020

First Posted

April 17, 2020

Study Start

June 1, 2020

Primary Completion

July 1, 2021

Study Completion

April 1, 2022

Last Updated

November 11, 2021

Record last verified: 2021-11

Locations

FR(1)