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

NCT06542380 | Completed

• 1 other identifier: DRKS00024852
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Pacemaker; TAVI; Risk Score

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pacemaker Implantation

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

  30 days after TAVI

Study Arms (1)

Patients undergoing TAVI at DHZC 2019-2021

Device: TAVI, pacemaker

Interventions

TAVI, pacemaker DEVICE

Retrospective analysis of need for pacemaker implantation after TAVI

Patients undergoing TAVI at DHZC 2019-2021

Eligibility Criteria

• Age: 51 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• German Heart Institute: lead

Study Sites (1)

Deutsches Herzzentrum der Charité

Mitte, State of Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Henryk Dreger, Professor

  German Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: August 7, 2024
• Study Start: February 7, 2022
• Primary Completion: November 30, 2023
• Study Completion: June 28, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-07

Locations

DE (1)