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

German Heart Institute

Status: Completed

Conditions: Pacemaker; Risk Score; TAVI

Treatments: Device: TAVI, pacemaker

Study type: Observational

Funder types: Other

Identifiers

NCT06542380

DRKS00024852

Details and patient eligibility

About

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.

Enrollment: 1,000 patients

Sex: All

Ages: 51 to 95 years old

Volunteers: No Healthy Volunteers

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)

Trial design

1,000 participants in 1 patient group

Patients undergoing TAVI at DHZC 2019-2021

Treatment:

Device: TAVI, pacemaker