Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
138 participants
OBSERVATIONAL
2020-06-01
2022-04-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Montpellier
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Florence Leclercq, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Montpellier
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Uhmontpellier
Montpellier, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RECHMPL20_0204
Identifier Type: -
Identifier Source: org_study_id