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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04350658
Other study ID # RECHMPL20_0204
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 1, 2020
Est. completion date April 1, 2022

Study information

Verified date November 2021
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 138
Est. completion date April 1, 2022
Est. primary completion date July 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - patients undergoing TAVR via transfemoral or rascoarotid access Exclusion criteria: - others access (subclavian, apical, transaortic)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Transcatheter aortic valve implantation required for symptomatic aortic stenosis
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.

Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Indidence of post dilatation Indidence of post dilatation 1 day
Secondary Underexpansion of the Edwards SAPIEN 3 THV Underexpansion of the Edwards SAPIEN 3 THV 1 day
Secondary risks factors of failure of crossing risks factors of failure of crossing : femoral vs carotid access, type of THV , vascular tortuosities, biscuipid valve, calcification, tight stenosis, horizontal aorta, small annulus 1 day
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