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Right ventricular endomyocardial biopsy for the assessment of cardiomyopathies: A monocentric safety and feasibility analysis.

Right ventricular endomyocardial biopsy for the assessment of cardiomyopathies: A monocentric safety and feasibility analysis.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00038165
Enrollment
500
Registered
2025-11-20
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

I40 I42.0 Z94.1 T86.2 E85.4 I42.1

Interventions

Group 1: Patients included in this study will undergo an endomyocardial biopsy (EMB) as part of the clinical diagnostic workup. During this procedure, endomyocardial tissue samples are obtained for fu

Sponsors

Westdeutsches Herz- und Gefäßzentrum, Klinik für Kardiologie und Angiologie, Universitätsklinikum Essen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Indication for endomyocardial biopsy (EMB) in routine clinical practice.

Exclusion criteria

Exclusion criteria: Pregnancy, under 18 years of age.

Design outcomes

Primary

MeasureTime frame
The primary endpoint of this study will be determined after completion of the endomyocardial biopsy (EMB) and subsequent data collection. The primary endpoint consists of procedure-related mortality, periprocedural arrhythmias, and pericardial effusion. Assessment of this endpoint will be based on examination findings and clinical documentation following the EMB. For this purpose, data from the procedure (EMB) and from the postprocedural echocardiography will be analyzed.

Secondary

MeasureTime frame
The secondary endpoint of this study will be determined after completion of the endomyocardial biopsy (EMB). The secondary endpoint consists of newly developed acute kidney injury and vascular complications at the access site. Assessment of this endpoint will be based on examination findings and clinical documentation following the EMB. For this purpose, data from the procedure (EMB) and from postprocedural blood sampling will be analyzed.

Countries

Germany

Contacts

Public ContactLars Michel

Westdeutsches Herz- und Gefäßzentrum Essen, Klinik für Kardiologie und Angiologie, Universitätsklinikum Essen

lars.michel@uk-essen.de+49020172384841

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026