Brief Title
Everyday Practice With Transcatheter Aortic Valve Implantation
Official Title
Experience With Percutaneous Transcatheter Aortic Valve Implantation in Patients With Symptomatic Aortic Valve Disease in Two German Centers
Brief Summary
The purpose of this registry is to document the everyday practice in our centers with minimal invasive treatment of patients with aortic valve disease who were considered suitable for transfemoral aortic valve implantation by heart team.
Detailed Description
The TAVI program in our center started on November 2007. As part of the national policy for quality assurance in medicine a detailed clinical characterization of the TAVI-population was required. Furthermore, a detailed description of the procedure and peri-procedural complications until discharge was required. In our center we designed and are routinely using a TAVI database which fulfills the authority requirements as well as has additional data needed for planning and documentation of TAVI procedure. Since there is already a considerable number of TAVI patients in this database we aim to perform statistical analyses answering different question in this filed.
Study Type
Observational
Primary Outcome
incidence of post-TAVI aortic regurgitation
Secondary Outcome
incidence of bleeding complications
Condition
Aortic Valve Stenosis
Intervention
aortic valve prostheses
Study Arms / Comparison Groups
TAVI patients
Description: all patients undergoing transcatheter aortic valve prostheses implantation
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
Device
Estimated Enrollment
2370
Start Date
November 2007
Completion Date
May 20, 2018
Primary Completion Date
April 20, 2018
Eligibility Criteria
Inclusion Criteria: - Aortic stenosis - Intermediate-to-high risk for surgery - Heart team decision Exclusion Criteria: - Contraindication to transfemoral TAVI procedure
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Julinda Mehilli, Prof. MD, ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT02289339
Organization ID
MucS001-14
Responsible Party
Principal Investigator
Study Sponsor
Klinikum der Universitaet Muenchen
Study Sponsor
Julinda Mehilli, Prof. MD, Principal Investigator, Cardiology Department, Munich University Clinic, Ludwig-Maximilian University
Verification Date
August 2018