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Completed

NCT Number: NCT03497611

Edwards SAPIEN 3 PPI Registry

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.

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Key information

Conditions

Aortic Valve Stenosis AV Block Aortic Valve Disease Aortic Valve, Calcification of Arrhythmias, Cardiac Atrioventricular Block Bundle-Branch Block Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Heart Valve Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Ventricular Outflow Obstruction

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transcatheter valve implantation

Procedure

aortic transcatheter valve implantation using Edwards SAPIEN 3 valve

Primary outcomes

  1. occurence of PPI after TAVI

    Time frame: 30 days

    need for permanent pacemaker implantation after TAVI

Secondary outcomes

  1. Timing of PPI

    Time frame: 30 days

    Time interval after TAVI until PPI in days

  2. 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
    • etc

Sponsors and collaborators

Lead sponsor

Institut für Pharmakologie und Präventive Medizin

Network

Collaborators

  • Edwards Lifesciences

Registry information

Official study 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

Acronym: Conduct

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Apr 13, 2018
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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