Patient Outcome After Cardiac Double Valve Replacement at University Hospital Basel/ Switzerland

Cardiac Double Valve Replacement Clinical Trial

Official title:

Patient Outcome After Cardiac Double Valve Replacement at University Hospital Basel/ Switzerland

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03667274
• Other study ID #: 2018-00553; ch18Grapow2
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: August 31, 2020

Study information

• Verified date: June 2021
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Double Valve Replacement

Intervention

Procedure:
• cardiac valve surgery
cardiac double valve surgery (aortic and mitral valve)

Locations

Country	Name	City	State
Switzerland	Herzchirurgie University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death	death after cardiac valve surgery	time from hospitalisation for cardiac valve surgery and following 12 months
Primary	re-surgery	re-surgery after cardiac valve surgery	time from hospitalisation for cardiac valve surgery and following 12 months
Primary	change in transvalvular gradient	change in transvalvular Gradient after cardiac valve surgery	time from hospitalisation for cardiac valve surgery and following 12 months