Clinical Follow up after implantation of the Edwards Intuity valve system

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00012950

Enrollment

190

Registered

2017-09-06

Start date

2017-09-13

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

Interventions

Group 1: Follow up study of all patients who received the edwards intuity aortic biobrosthese since 2012. Examination of clinical and echocardiographic results after 12 months and 3 years. On the one

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: All patients who received AVR (Aortic valve replacement) with the Edwards Intuity valve since 2012

Exclusion criteria

Exclusion criteria: no informed consent

Design outcomes

Primary

Measure	Time frame
Mortality (valve related/ non valve related)	—

Secondary

Measure	Time frame
2. stroke rate after 12months and 3 years - data acquisition with anamnesis form 3. endocarditis rate after 12months and 3 years -data acquisition with anamnesis form and echocardiographic examination 4. valve thrombosis rate after 12months and 3 years-data acquisition with anamnesis form and echocardiographic examination 5. valve degeneration after 12months and 3 years- data acquisition with anamnesis form and echocardiographic examination 6. rate of bleeding after 12months and 3 years data acquisition with anamnesis form 7. re-operation rate after 12months and 3 years- data acquisition with anamnesis form 8. acute and chronic postoperative pain after 12months and 3 years-data acquisition with anamnesis form	—

Measure

Time frame

2. stroke rate after 12months and 3 years - data acquisition with anamnesis form 3. endocarditis rate after 12months and 3 years -data acquisition with anamnesis form and echocardiographic examination 4. valve thrombosis rate after 12months and 3 years-data acquisition with anamnesis form and echocardiographic examination 5. valve degeneration after 12months and 3 years- data acquisition with anamnesis form and echocardiographic examination 6. rate of bleeding after 12months and 3 years data acquisition with anamnesis form 7. re-operation rate after 12months and 3 years- data acquisition with anamnesis form 8. acute and chronic postoperative pain after 12months and 3 years-data acquisition with anamnesis form

—

Countries

Germany

Contacts

Public ContactMarkus Schlömicher

Klinik für Herz- ThoraxchirurgieUniversitätsklinikum Bergmannsheil Bochum

markus.schloemicher@bergmannsheil.de0234 302 3305

Outcome results

None listed

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