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Clinical Trials/NCT03798015
NCT03798015
Withdrawn
Not Applicable

Neurologic Outcome After Mitral Valve Surgery

University Hospital, Basel, Switzerland1 site in 1 countryFebruary 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mitral Valve Reconstruction
Sponsor
University Hospital, Basel, Switzerland
Locations
1
Primary Endpoint
occurence of stroke (yes/ no) subsequent to mitral valve surgery
Status
Withdrawn
Last Updated
4 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
February 2009
End Date
December 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Basel, Switzerland
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

occurence of stroke (yes/ no) subsequent to mitral valve surgery

Time Frame: post surgical from day of surgery until day of discharge from hospital (approx. 2 weeks)

assessment of ischemic or hemorrhagic stroke subsequent to mitral valve surgery

Study Sites (1)

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