Edwards SAPIEN 3 PPI Registry

Aortic Valve Stenosis Clinical Trial

— Conduct  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03497611
• Other study ID #: Conduct
• Status: Completed
• Start date: April 30, 2018
• Est. completion date: March 3, 2019

Study information

• Verified date: September 2020
• Source: Institut für Pharmakologie und Präventive Medizin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: March 3, 2019
• Est. primary completion date: November 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• AV Block
• Bundle-Branch Block

Intervention

Procedure:
• transcatheter valve implantation
aortic transcatheter valve implantation using Edwards SAPIEN 3 valve

Locations

Country	Name	City	State
Germany	Herzzentrum, Universität Köln	Cologne	Nordrhein-Westfalen
Germany	Universitätsklinikum Münster, Klinik und Poliklinik für Erwachsene mit angeborenen und erworbenen Herzfehlern	Münster	Nordrhein-Westfalen
Germany	University Clinic Tübingen, Department of Internal Medicine III	Tübingen	Baden-Württemberg
Germany	University Clinic Ulm, Department of Internal Medicine II	Ulm	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
Institut für Pharmakologie und Präventive Medizin	Edwards Lifesciences

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Droppa M, Rudolph TK, Baan J, Nielsen NE, Baumgartner H, Vendrik J, Froehlich M, Borst O, Wöhrle 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 implant — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurence of PPI after TAVI	need for permanent pacemaker implantation after TAVI	30 days
Secondary	Timing of PPI	Time interval after TAVI until PPI in days	30 days
Secondary	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	30 days