Brief Title
TAVR Without Predilatation
Official Title
Feasibility and Safety of TAVI Without Predilatation: an Observational All Comers Study
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.
Study Type
Observational
Primary Outcome
success of the direct implantation
Secondary Outcome
Indidence of post dilatation
Condition
Aortic Stenosis
Intervention
Transcatheter aortic valve implantation required for symptomatic aortic stenosis
Study Arms / Comparison Groups
TAVR
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
138
Start Date
June 1, 2020
Completion Date
April 1, 2022
Primary Completion Date
May 1, 2021
Eligibility Criteria
Inclusion criteria: - patients undergoing TAVR via transfemoral or rascoarotid access Exclusion criteria: - others access (subclavian, apical, transaortic)
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Florence Leclercq, MD, PhD, 4.67.33.67.33, [email protected]
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT04350658
Organization ID
RECHMPL20_0204
Responsible Party
Sponsor
Study Sponsor
University Hospital, Montpellier
Study Sponsor
Florence Leclercq, MD, PhD, Principal Investigator, University Hospital, Montpellier
Verification Date
July 2020