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

August 4, 2024 updated by: Julia Lueg, German Heart Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Berlin
      • Berlin-Mitte, Berlin, Germany, 10117
        • Deutsches Herzzentrum der Charité

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Given the retrospective nature of the study, all patients who had undergone TAVI at the DHZC were included, with the exception of those meeting the exclusion criteria mentioned above. Consequently, the study population is primarily comprised of individuals aged 75 years and above, with a balanced gender distribution.

Following current guidelines, every patient undergoing TAVI received an initial assessment by a multidisciplinary heart team.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients undergoing TAVI at DHZC 2019-2021
Device: TAVI, pacemaker
Retrospective analysis of need for pacemaker implantation after TAVI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pacemaker Implantation
Time Frame: 30 days after TAVI
Rate of pacemaker implantation up to 30 days after TAVI according to current guidelines
30 days after TAVI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Heart Institute

Investigators

  • Principal Investigator: Henryk Dreger, Professor, German Heart Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2022

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

June 28, 2024

Study Registration Dates

First Submitted

July 19, 2024

First Submitted That Met QC Criteria

August 4, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 4, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DRKS00024852

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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