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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06542380
Acronym
TAVI PACER
Enrollment
1000
Registered
2024-08-07
Start date
2022-02-07
Completion date
2024-06-28
Last updated
2024-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pacemaker, Risk Score, TAVI

Keywords

Transcatheter aortic valve replacement, Aortic stenosis, Pacemaker implantation, Risk Score, Electrocardiogram, Risk Stratification

Brief summary

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.

Interventions

DEVICETAVI, pacemaker

Retrospective analysis of need for pacemaker implantation after TAVI

Sponsors

German Heart Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
51 Years to 95 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Pacemaker Implantation30 days after TAVIRate of pacemaker implantation up to 30 days after TAVI according to current guidelines

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026