Edwards SAPIEN 3 PPI Registry

Completed

• Conditions: Bundle-Branch Block; Aortic Valve Stenosis; AV Block
• Interventions: Procedure: transcatheter valve implantation

• Registration Number: NCT03497611
• Lead Sponsor: Institut für Pharmakologie und Präventive Medizin

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.

Study Timeline

• Study First Submitted: 2018-03-26
• Study First Submitted QC: 2018-04-06
• Study First Posted: 2018-04-13
• Study Start: 2018-04-30
• Primary Completion: 2018-11-03
• Study Completion: 2019-03-03
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-02
• Last Update Posted: 2020-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with aortic stenosis	transcatheter valve implantation	Patients receiving Edwards SAPIEN 3 Transcatheter aortic valve implantation

Primary Outcome Measures

Name	Time	Method
occurence of PPI after TAVI	30 days	need for permanent pacemaker implantation after TAVI

Secondary Outcome Measures

Name	Time	Method
Indications for PPI	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; * etc
Timing of PPI	30 days	Time interval after TAVI until PPI in days

Trial Locations

Locations (4)

University Clinic Ulm, Department of Internal Medicine II; 🇩🇪 Ulm, Baden-Württemberg, 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

Herzzentrum, Universität Köln; 🇩🇪 Cologne, Nordrhein-Westfalen, Germany