Edwards SAPIEN 3 PPI Registry (Conduct)
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|ClinicalTrials.gov Identifier: NCT03497611|
Recruitment Status : Completed
First Posted : April 13, 2018
Last Update Posted : September 4, 2020
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.
|Condition or disease||Intervention/treatment|
|Aortic Valve Stenosis AV Block Bundle-Branch Block||Procedure: transcatheter valve implantation|
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.
|Study Type :||Observational|
|Actual Enrollment :||1000 participants|
|Official Title:||Edwards SAPIEN 3 PPI Registry - A Retrospective Survey and Prospective Identification of Procedure Related Variables Associated With Permanent Pacemaker Implantation in Patients Receiving an Edwards SAPIEN 3 Valve|
|Actual Study Start Date :||April 30, 2018|
|Actual Primary Completion Date :||November 3, 2018|
|Actual Study Completion Date :||March 3, 2019|
Patients with aortic stenosis
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 [ Time Frame: 30 days ]need for permanent pacemaker implantation after TAVI
- Timing of PPI [ Time Frame: 30 days ]Time interval after TAVI until PPI in days
- Indications for PPI [ Time Frame: 30 days ]
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03497611
|University Clinic Tübingen, Department of Internal Medicine III|
|Tübingen, Baden-Württemberg, Germany, 72076|
|University Clinic Ulm, Department of Internal Medicine II|
|Ulm, Baden-Württemberg, Germany, 89073|
|Herzzentrum, Universität Köln|
|Cologne, Nordrhein-Westfalen, Germany, 50937|
|Universitätsklinikum Münster, Klinik und Poliklinik für Erwachsene mit angeborenen und erworbenen Herzfehlern|
|Münster, Nordrhein-Westfalen, Germany, 48149|
|Principal Investigator:||Tobias Geisler, Prof.||University Clinic Tübingen, Tübingen, Germany - Department of Internal Medicine III|