Neurologic Outcome After Mitral Valve Surgery

April 12, 2022 updated by: University Hospital, Basel, Switzerland

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Herzchirurgie University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients undergoing a surgical mitral valve reconstruction or replacement at the University Hospital Basel from 2009 until today

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
mitral valve surgery
outcome of mitral valve surgery (stroke yes or no)
Other: mitral valve surgery
assessment of ischemic or hemorrhagic stroke subsequent to mitral valve surgery

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Martin Grapow, Prof. Dr. MD, Klinik für Herzchirurgie, Universitätsspital Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2009

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

January 7, 2019

First Submitted That Met QC Criteria

January 7, 2019

First Posted (Actual)

January 9, 2019

Study Record Updates

Last Update Posted (Actual)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 12, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2018-02143; ch18Grapow3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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