Neurologic Outcome After Mitral Valve Surgery

NCT03798015 | Withdrawn

• 1 other identifier: 2018-02143; ch18Grapow3
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Valve Reconstruction

Keywords

mitral valve surgery; mitral valve stenosis; mitral valve insufficiency; minimal invasive mitral valve surgery; neurological outcome

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

mitral valve surgery

outcome of mitral valve surgery (stroke yes or no)

Other: mitral valve surgery

Interventions

mitral valve surgery OTHER

assessment of ischemic or hemorrhagic stroke subsequent to mitral valve surgery

mitral valve surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• pre- existing neurological deficit; neurologic limitation in daily life
• emergency surgery

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Herzchirurgie University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Mitral Valve Stenosis; Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Martin Grapow, Prof. Dr. MD

  Klinik für Herzchirurgie, Universitätsspital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 9, 2019
• Study Start: February 1, 2009
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 20, 2022

Record last verified: 2022-04

Locations

CH (1)