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German David Registry: Outcomes and risk factors of failure after valve-sparing aortic root replacement

German David Registry: Outcomes and risk factors of failure after valve-sparing aortic root replacement - German David Registry

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00007872
Enrollment
1000
Registered
2015-03-12
Start date
2016-10-27
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

I35.1

Interventions

Group 1: A national multicentre, retrospective, risk factor study is proposed. The study design is nonrandomized and non-blinded. This retrospective study will serve as a basis for the establishment o

Sponsors

Universitäts-Herzzentrum Freiburg Bad Krozingen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients who underwent one of the variants of the David valve-sparing aortic root replacement procedure as a primary procedure (I-V, intention to treat) with or without the addition of aortic valve cusp and/or commissure repair - Aortic root aneurysm AND/OR - Ascending aortic aneurysm OR - Acute aortic dissection OR - Bicuspid aortic valve OR - Tricuspid aortic valve - Any degree of aortic valve regurgitation - Syndromic patients including Marfan Syndrome, Loeys-Dietz Syndrome, Ehlers-Danlos Syndrome OR - Non-syndromic patients

Exclusion criteria

Exclusion criteria: - More than mild aortic valve stenosis - Aortic valve endocarditis - Reoperation - Redo-Operation - Valve not suitable for valve-sparing operation

Design outcomes

Primary

MeasureTime frame
- Reoperation at five and ten years after the procedure - Aortic valve replacement using a prosthesis five and ten years after the procedure

Secondary

MeasureTime frame
Residual aortic valve regurgitation, progression of aortic valve regurgitation, new onset aortic valve regurgitation, incidence of more than mild / severe aortic valve regurgitation. Time points for all mentioned endpoints is at five and ten years after the primary procedure.

Countries

Germany

Contacts

Public ContactFabian Kari

Universitäts-Herzzentrum Freiburg - Bad Krozingen

fabian.alexander.kari@universitaets-herzzentrum.de0761 270 26550

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026