Establishing a cardiology registry: navigating quality and regulatory challenges with a focus on congenital heart disease

Pittrow R, Dewald O, Harig F, Kaemmerer-Suleiman AS, Suleiman M, Pittrow LB, Achenbach S, Freiberger A, Freilinger S, Pittrow BA, Kaulitz R, Kaemmerer H (2025)

Publication Type: Journal article, Review article

Publication year: 2025

Journal

Cardiovascular Diagnosis and Therapy AME Publishing Company

Book Volume: 15

Pages Range: 455-464

Journal Issue: 2

DOI: 10.21037/cdt-2024-579

Abstract

Registries have become pivotal in medical research, offering a robust foundation for understanding disease incidence, treatment patterns, and patient outcomes across diverse populations. By aggregating real-world data (RWD), registries provide invaluable insights into real-world evidence (RWE), shaping clinical guidelines, healthcare policies, and regulatory decisions. Their widespread acceptance underscores their scientific validity and their role in driving evidence-based medicine, ultimately improving healthcare outcomes. In cardiology, particularly within the specialized field of congenital heart disease (CHD), national and international registries have emerged as indispensable tools. They enable the systematic collection of data on patient demographics, disease progression, therapeutic interventions, and long-term outcomes. These datasets support a range of purposes, including observational studies, quality improvement initiatives, and regulatory assessments of medical devices or pharmaceuticals. Establishing a high-quality registry requires meticulous planning and adherence to established guidelines. Professional organizations, such as the European Society of Cardiology (ESC) and the American Heart Association (AHA), offer detailed guidance documents for setting up and managing registries. Additionally, various checklists and frameworks exist to evaluate and ensure registry quality, aiding researchers in optimizing data reliability and utility. With advancements in digital health, the potential of electronic health records (EHRs) to complement or replace traditional registries is increasingly explored. EHRs offer a dynamic, real-time data collection mechanism, reducing redundancy and operational costs while maintaining data accuracy. However, considerations around interoperability, data privacy, and standardization remain critical in leveraging EHRs for registry purposes.

Authors with CRIS profile

Robert Pittrow Department of Cardiac Surgery Oliver Dewald Department of Cardiac Surgery Frank Harig Department of Cardiac Surgery Ann-Sophie Kaemmerer-Suleiman Department of Cardiac Surgery Mathieu Suleiman Department of Cardiac Surgery Stephan Achenbach Lehrstuhl für Innere Medizin II

Involved external institutions

Technische Universität München (TUM) DE Germany (DE) Universitätsklinikum Tübingen DE Germany (DE)

How to cite

APA:

Pittrow, R., Dewald, O., Harig, F., Kaemmerer-Suleiman, A.-S., Suleiman, M., Pittrow, L.B.,... Kaemmerer, H. (2025). Establishing a cardiology registry: navigating quality and regulatory challenges with a focus on congenital heart disease. Cardiovascular Diagnosis and Therapy, 15(2), 455-464. https://doi.org/10.21037/cdt-2024-579

MLA:

Pittrow, Robert, et al. "Establishing a cardiology registry: navigating quality and regulatory challenges with a focus on congenital heart disease." Cardiovascular Diagnosis and Therapy 15.2 (2025): 455-464.

BibTeX: Download