An observational study in Aortic Valve Stenosis, sponsored by LMU Klinikum. Completed at 2 sites in Germany. Per ClinicalTrials.gov, last updated 2018-08-13.
Sponsored by LMU Klinikum · Observational
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.
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.
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
This study's enrollment of 2,370 is above the median of 200 across 424 observational studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →LMU Klinikum is the lead sponsor of 51 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients with aortic valve stenosis suitable for transfemoral transcatheter aortic valve implanation
Exclusion Criteria:
all patients undergoing transcatheter aortic valve prostheses implantation
Device: aortic valve prostheses
balloon-expandable and self-expandable aortic valve prostheses
Also known as: CoreValve, CoreValveE, Sapien XT, Sapien S3, Lotus
incidence of post-TAVI aortic regurgitation
echocardiographicall and angiographycally determined
Time frame: 30 days
incidence of bleeding complications
defined according to BARC and VARC-2 classification
Time frame: 30 days
mortality
all-cause and cardio/cerebrovascular death
Time frame: 30 days
mortality rate
all-cause and cardio/cerebrovascular death
Time frame: 2-years
mortality rate
all-cause and cardio/cerebrovascular death
Time frame: 5-years
incidence of cerebrovascular events
stroke or TIA
Time frame: 30 days
incidence of cerebrovascular events
stroke or TIA
Time frame: 2-years
incidence of cerebrovascular events
stroke or TIA
Time frame: 5-years
incidence of new pacemaker implantation
pacemaker after TAVI
Time frame: 30-day
incidence of new pacemaker implantation
pacemaker after TAVI
Time frame: 1-year
incidence of vascular complications
defined according to VARC-2 classification
Time frame: 30 days
incidence of re-hospitalisation
new unplanned hospital stay due to cardiovascular und cerebrovascular reasons
Time frame: 2-year
incidence of re-hospitalisation
new unplanned hospital stay due to cardiovascular und cerebrovascular reasons
Time frame: 5-year
Plan to share: Undecided
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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