Patient Outcome After Cardiac Double Valve Replacement at University Hospital Basel/ Switzerland
Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Completed
CT.gov ID
NCT03667274
Collaborator
(none)
106
1
29
3.7
Study Details
Study Description
Brief Summary
To compare patient outcome data after cardiac double valve replacement (aortic and mitral valve) with patient outcome data after aortic valve replacement and mitral valve reconstruction
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
To compare patient outcome data ( death, re-surgery, change in transvalvular gradient) after cardiac double valve replacement (aortic and mitral valve) with patient outcome data after aortic valve replacement and mitral valve reconstruction in patients with cardiac surgery at University Hospital Basel/ Switzerland since 2009.
Study Design
Study Type:
Observational
Actual Enrollment
:
106 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Patient Outcome After Cardiac Double Valve Replacement at University Hospital Basel/ Switzerland
Actual Study Start Date
:
Apr 1, 2018
Actual Primary Completion Date
:
Aug 31, 2020
Actual Study Completion Date
:
Aug 31, 2020
Outcome Measures
Primary Outcome Measures
- death [time from hospitalisation for cardiac valve surgery and following 12 months]
death after cardiac valve surgery
- re-surgery [time from hospitalisation for cardiac valve surgery and following 12 months]
re-surgery after cardiac valve surgery
- change in transvalvular gradient [time from hospitalisation for cardiac valve surgery and following 12 months]
change in transvalvular Gradient after cardiac valve surgery
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- patients undergoing cardiac double valve surgery (aortic valve replacement, mitral valve replacement, mitral valve reconstruction) at University Hospital Basel/ Switzerland, starting 2009
Exclusion Criteria:
- denial of consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Herzchirurgie University Hospital Basel | Basel | Switzerland | 4031 |
Sponsors and Collaborators
- University Hospital, Basel, Switzerland
Investigators
- Principal Investigator: Martin Grapow, Prof. Dr. MD, University Hospital, Basel, Switzerland
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT03667274
Other Study ID Numbers:
- 2018-00553; ch18Grapow2
First Posted:
Sep 12, 2018
Last Update Posted:
Jun 22, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Basel, Switzerland