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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-07

Study Completion Date

2024-06-28

Brief Summary

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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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Detailed Description

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Conditions

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Pacemaker TAVI Risk Score

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients undergoing TAVI at DHZC 2019-2021

TAVI, pacemaker

Intervention Type DEVICE

Retrospective analysis of need for pacemaker implantation after TAVI

Interventions

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TAVI, pacemaker

Retrospective analysis of need for pacemaker implantation after TAVI

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

51 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No