Neurologic Outcome After Mitral Valve Surgery

Mitral Valve Reconstruction Clinical Trial

Official title:

Neurologic Outcome After Mitral Valve Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03798015
• Other study ID #: 2018-02143; ch18Grapow3
• Status: Withdrawn
• Start date: February 2009
• Est. completion date: December 2021

Study information

• Verified date: April 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Reconstructive mitral valve surgery is increasingly done by minimal- invasive anterolateral thoracotomy technique in contrast to surgical approach by sternotomy. The minimal invasive approach is favourable regarding surgical trauma, length of hospital stay and amount of blood loss. This study is to investigate the neurological outcome after minimal- invasive mitral valve surgery compared to open mitral valve surgery by sternotomy. Pre-, intra- and postsurgical data from mitral valve surgery derived from the Basel mitral valve registry (collected from 2009 until now) will be analyzed.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• surgery for mitral valve (reconstruction or replacement) (maybe combined with surgery for tricuspid valve and/ or surgery for atrial septal defects and/or patent foramen ovale)

Exclusion Criteria:

• other surgical interventions then the surgical interventions mentioned in the inclusion criteria
• pre- existing neurological deficit; neurologic limitation in daily life
• emergency surgery

Related Conditions & MeSH terms

• Mitral Valve Reconstruction

Intervention

Other:
• mitral valve surgery
assessment of ischemic or hemorrhagic stroke subsequent to mitral valve surgery

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	occurence of stroke (yes/ no) subsequent to mitral valve surgery	assessment of ischemic or hemorrhagic stroke subsequent to mitral valve surgery	post surgical from day of surgery until day of discharge from hospital (approx. 2 weeks)