TAVI PACER: A Two-step Risk Score for Prediction of Permanent Pacemaker Implantation After TAVI.

The need for permanent pacemaker implantation (PPMI) remains one of the most frequent complications after transcatheter aortic valve implantation (TAVI). This study aimed to develop a novel, two-step risk score to predict PPMI probability after TAVI and to implement it into a user-friendly website. Our risk score addresses the gap in existing data on current prosthesis generations and provides a new and clinically motivated approach to calculating the risk for PPMI.

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Key information

Conditions

Pacemaker Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Risk Score TAVI Ventricular Outflow Obstruction

Age range

51 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Deutsches Herzzentrum der Charité

Mitte, State of Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients undergoing TAVI at Deutsches Herzzentrum der Charité between January 2019 and December 2020

Exclusion criteria

previous device implantation
valve-in-valve procedure
patients who had received an ALLEGRATM valve (NVT AG, Morges, Switzerland), a LOTUS EdgeTM valve (Boston, Scientific, Natick, Massachusetts), or a CENTERATM valve (Edwards Lifesciences, Irvine, California)

Treatment and study plan

TAVI, pacemaker

Device

Retrospective analysis of need for pacemaker implantation after TAVI

Primary outcomes

Pacemaker Implantation

Time frame: 30 days after TAVI

Rate of pacemaker implantation up to 30 days after TAVI according to current guidelines

Sponsors and collaborators

Lead sponsor

German Heart Institute

Other

Registry information

Acronym: TAVI PACER

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2024
First posted: Aug 7, 2024
Registry last updated: Aug 7, 2024

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.

Published trials that share one or more normalized conditions with this study.

Completed