Trifecta™-10 year results - A monocentric observational study to evaluate the long term results after aortic valve replacement with the Trifecta ™-bioprosthetis

Trifecta™-10 year results - A monocentric observational study to evaluate the long term results after aortic valve replacement with the Trifecta ™-bioprosthetis - Trifecta 5y

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00007578

Enrollment

Registered

2014-12-02

Start date

2014-12-06

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

I35.0 I35.1

Interventions

Group 1: An annual follow-up should take place over a period of five years. In this follow-up an echocardiographic examination should occur, to determine the functionality of the Trifecta biological p

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: All patients who have received a trifecta biological prosthesis at the heart centre Leipzig during the European pivotal study (CS05002TV) and who have given informed consent for this study.

Exclusion criteria

Exclusion criteria: Patients who did not signed the informed consent form.

Design outcomes

Primary

Measure	Time frame
functioning of Trifecta bioprosthesis by annual echocardiographic examination for 5 years	—

Secondary

Measure	Time frame
Analysis of the clinical symptoms, adverse events, survival rates, re operations, occurrence of endocarditis and stroke within 5 years	—

Countries

Germany

Contacts

Public ContactSven Lehmann

Herzzentrum Leipzig GmbH - Universitätsklinik für Herzchirurgie

Sven.Lehmann2@helios-kliniken.de0341 865 251028

Outcome results

None listed

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