Clinical trial NCT03497611: Edwards SAPIEN 3 PPI Registry
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
AV Block
Bundle-Branch Block
Keywords: Transcatheter aortic valve implantation
Pacemaker
Aortic valve calcification
PPI
Lead sponsor: Institut für Pharmakologie und Präventive Medizin
Sponsor class: NETWORK
Collaborators: name: Edwards Lifesciences
First posted: 2018-04-13
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that already underwent transfemoral transcatheter valve implantation with the SAPIEN 3 valve

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients that already underwent Edwards SAPIEN 3 implantation because of aortic stenosis

Exclusion Criteria:

* Patients with prior pacemaker or intended valve in valve implantation

Primary outcomes:
measure: occurence of PPI after TAVI
timeFrame: 30 days
Secondary outcomes:
measure: Timing of PPI
timeFrame: 30 days
measure: Indications for PPI
timeFrame: 30 days
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Clinic Tübingen, Department of Internal Medicine III
state: Baden-Württemberg
city: Ulm
country: Germany
facility: University Clinic Ulm, Department of Internal Medicine II
state: Baden-Württemberg
city: Cologne
country: Germany
facility: Herzzentrum, Universität Köln
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Universitätsklinikum Münster, Klinik und Poliklinik für Erwachsene mit angeborenen und erworbenen Herzfehlern
state: Nordrhein-Westfalen
Study officials:
affiliation: University Clinic Tübingen, Tübingen, Germany - Department of Internal Medicine III
name: Tobias Geisler, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Droppa M, Rudolph TK, Baan J, Nielsen NE, Baumgartner H, Vendrik J, Froehlich M, Borst O, Wohrle J, Gawaz M, Potratz P, Hack LP, Mauri V, Baranowski J, Bramlage P, Kurucova J, Thoenes M, Rottbauer W, Geisler T. Risk factors for permanent pacemaker implantation in patients receiving a balloon-expandable transcatheter aortic valve prosthesis. Heart Vessels. 2020 Dec;35(12):1735-1745. doi: 10.1007/s00380-020-01653-6. Epub 2020 Jun 26.