Neurologic Outcome After Mitral Valve Surgery | NCT03798015

Studies
Neurologic Outcome After Mitral Valve Surgery

NCT03798015

Sponsor

University Hospital, Basel, Switzerland

Status

Withdrawn

Last Update Posted

Apr 20, 2022Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Mitral Valve Reconstruction

Interventions

mitral valve surgery

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

resource issues on site

Expanded Access Info

Start Date

Feb 2009Actual

Primary Completion Date

Dec 2021Actual

Completion Date

Dec 2021Actual

First Submitted Date

Jan 7, 2019

First Submission Date that Met QC Criteria

Jan 7, 2019

First Posted Date

Jan 9, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2022

Last Update Posted Date

Apr 20, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
mitral valve surgery		outcome of mitral valve surgery (stroke yes or no)	Other: mitral valve surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mitral valve surgery	Other	assessment of ischemic or hemorrhagic stroke subsequent to mitral valve surgery	mitral valve surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martin Grapow, Prof. Dr. MD	Klinik für Herzchirurgie, Universitätsspital Basel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Herzchirurgie University Hospital Basel		Basel		4031	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D008946	Mitral Valve Stenosis
D008944	Mitral Valve Insufficiency

Ancestor Terms

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided