Edwards SAPIEN 3 PPI Registry

NCT ID: NCT03497611

Last Updated: 2020-09-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-30
• Study Completion Date: 2019-03-03

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.

Conditions

Aortic Valve Stenosis; AV Block; Bundle-Branch Block

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients with aortic stenosis

Patients receiving Edwards SAPIEN 3 Transcatheter aortic valve implantation

transcatheter valve implantation

Intervention Type: PROCEDURE

aortic transcatheter valve implantation using Edwards SAPIEN 3 valve

Interventions

transcatheter valve implantation

aortic transcatheter valve implantation using Edwards SAPIEN 3 valve

Intervention Type: PROCEDURE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: collaborator

Institut für Pharmakologie und Präventive Medizin

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tobias Geisler, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Clinic Tübingen, Tübingen, Germany - Department of Internal Medicine III

Locations

University Clinic Tübingen, Department of Internal Medicine III

Tübingen, Baden-Wurttemberg, Germany

University Clinic Ulm, Department of Internal Medicine II

Ulm, Baden-Wurttemberg, Germany

Herzzentrum, Universität Köln

Cologne, North Rhine-Westphalia, Germany

Universitätsklinikum Münster, Klinik und Poliklinik für Erwachsene mit angeborenen und erworbenen Herzfehlern

Münster, North Rhine-Westphalia, Germany

Countries

Germany

References

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.

Reference Type: RESULT

PMID: 32591894 (View on PubMed)

Rudolph T, Droppa M, Baan J, Nielsen NE, Baranowski J, Hachaturyan V, Kurucova J, Hack L, Bramlage P, Geisler T. Modifiable risk factors for permanent pacemaker after transcatheter aortic valve implantation: CONDUCT registry. Open Heart. 2023 Feb;10(1):e002191. doi: 10.1136/openhrt-2022-002191.

Reference Type: DERIVED

PMID: 36750275 (View on PubMed)

Other Identifiers

Conduct

Identifier Type: -

Identifier Source: org_study_id