An observational study in Aortic Valve Stenosis, AV Block and Bundle-Branch Block, sponsored by Institut für Pharmakologie und Präventive Medizin. Completed at 4 sites in Germany. Per ClinicalTrials.gov, last updated 2020-09-04.
Sponsored by Institut für Pharmakologie und Präventive Medizin · Observational
There are patient related risk factors for PPI that can be identified and assessed in retrospective pooling of 1000+ TAVI patient datasets.
Retrospective pooling of 6 datasets already available at participating centres (4 sites in Germany, 1 in Zwolle / The Netherlands, 1 in Linköping / Sweden).
Additional assessment of calcifications using a CT data core lab. Statistical analysis of the obtained dataset with respect to the objectives of the registry.
Permanent pacemaker implantation is a widely recognized clinical event associated with TAVI becoming evident within a few days after the procedure.
While a number of registries have documented the rates of PPI with different valves, much less evidence has been provided for 1) patient based characteristics (e.g. RBBB etc.) affecting the likelihood of PPI and for 2) procedural variables (e.g. implantation depth, valve size etc.) that should be considered to perform an as safe and minimal invasive procedure as possible.
Prior research To date there are 7 published reports on pacemaker rates and predictors associated with the use of the Edwards SAPIEN 3 THV (see Table). These studies suggest that the need for pacemaker implantation in single centers ranges between 14.4 and 20.4% derived from patient numbers between 131 and 335. These analyses resulted in the identification of pre-existing conduction disturbance / aortic valve calcification as patient related and implantation depth /oversizing as procedure related variables associated with Edwards SAPIEN 3 THV TAVI. Furthermore a scoring algorithm for patient related factors has been proposed from a dataset of 240 patients to predict the likelihood of PPI after THV .
Limitations of prior research Current evidence though is limited by patient numbers versus event rates (with a max. of 62 PPI considered in any of the available datasets) resulting in a limited power in multivariable analyses, the single center design of these ventures, the lack of a consistent definition of variables potentially associated and the unexplained differences in the number and type of variables identified.
Aims For this reason the investigators consider it necessary to 1) to retrospectively pool data from all of these 7 datasets to arrive at a more comprehensive picture of patient related variables (retrospective part I), to 2) assess procedural variables in a prospective multicenter registry (prospective part II) and 3) to potentially validate the identified variables in a future prospective cohort.
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
This study's enrollment of 1,000 is above the median of 200 across 435 observational studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Institut für Pharmakologie und Präventive Medizin is the lead sponsor of 30 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients that already underwent transfemoral transcatheter valve implantation with the SAPIEN 3 valve
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients receiving Edwards SAPIEN 3 Transcatheter aortic valve implantation
Procedure: transcatheter valve implantation
aortic transcatheter valve implantation using Edwards SAPIEN 3 valve
occurence of PPI after TAVI
need for permanent pacemaker implantation after TAVI
Time frame: 30 days
Timing of PPI
Time interval after TAVI until PPI in days
Time frame: 30 days
Indications for PPI
possible reasons to implant a PP: * 1° AV block * complete RBBB * complete LBBB * QRS duration prolonged * LVOT calcium volume below the left and right cusp * etc
Time frame: 30 days
Plan to share: No — no IPD will be made available
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Institut für Pharmakologie und Präventive Medizin