TAVR Without Predilatation

• Conditions: Aortic Stenosis
• Interventions: Procedure: Transcatheter aortic valve implantation required for symptomatic aortic stenosis

• Registration Number: NCT04350658
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-04-15
• Study First Posted: 2020-04-17
• Study Start: 2020-06-01
• Primary Completion: 2021-07-01
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-10
• Last Update Posted: 2021-11-11
• Study Completion: 2022-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TAVR	Transcatheter aortic valve implantation required for symptomatic aortic stenosis	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

Primary Outcome Measures

Name	Time	Method
success of the direct implantation	1 day	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

Secondary Outcome Measures

Name	Time	Method
Indidence of post dilatation	1 day	Indidence of post dilatation
Underexpansion of the Edwards SAPIEN 3 THV	1 day	Underexpansion of the Edwards SAPIEN 3 THV
risks factors of failure of crossing	1 day	risks factors of failure of crossing : femoral vs carotid access, type of THV , vascular tortuosities, biscuipid valve, calcification, tight stenosis, horizontal aorta, small annulus

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France