Minimal Invasive Mitral Valve Replacement Versus Conventi... | NCT03195595

Studies
Minimal Invasive Mitral Valve Replacement Versus Conventional Median Sternotomy Approach

NCT03195595

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Jun 12, 2020Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Mitral Valve Disease

Interventions

mitral valve replacement
conventional mitral valve replacement

Countries

Egypt

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

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2020Actual

Primary Completion Date

Oct 31, 2021Estimated

Completion Date

Oct 31, 2021Estimated

First Submitted Date

Jun 5, 2017

First Submission Date that Met QC Criteria

Jun 21, 2017

First Posted Date

Jun 22, 2017Actual

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

Jun 11, 2020

Last Update Posted Date

Jun 12, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elhussein Mohamed Abdelmottaleb, Resident doctor at cardiothoracic surgery, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

This is retrospective study that will be done in Cardiothoracic surgery department in Assuit university hospitals for one year duration aiming to compare minimal invasive technique to conventional median sternotomy for mitral valve surgery regarding early postoperative outcomes and pain

Detailed Description

This is retrospective study that will be done in Cardiothoracic surgery department in Assuit university hospitals for one year duration and the study tools will be:

Part I (Demographic data):

Age, Gender, Weight, Height ,Smoke history

Part II (Preoperative data):

Medical history, Clinical assessment, Preoperative investigation

Part III (Intraoperative data):

Surgical time, and Ischemic time

Part IV (Postoperative data):

Early ambulation, ICU stay, length of ventilation, using of analgesic drugs, post op bleeding, deaths

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
mitral valve replacement		patients whom underwent Mitral valve replacement through minimal invasive incision	Device: mitral valve replacement Device: conventional mitral valve replacement
conventional mitral valve replacement		patients whom underwent Mitral valve replacement through conventional sternotomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mitral valve replacement	Device	early postoperative outcome regarding pain in minimal invasive technique	mitral valve replacement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluating of postoperative pain by using numerical rating scales (NRS)	its a score result from gathered information from the patient	one year

Secondary Outcomes

Measure	Description	Time Frame
Evaluating early postoperative outcome	e.g., bleeding	one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Symptomatic patients with mitral valve disease indicated for valve surgery

Exclusion Criteria:

Double valve disease or other valve disease
Mitral or aortic valve disease associated with ischemic heart disease
Mitral or aortic valve disease associated with congenital heart disease
Patients subjected to prior heart surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

It includes groups of population above age of 18 with symptomatic mitral valve disease indicated for valve surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Elhussein abdelmottaleb, master	Contact	00201003873076		husseinmoh24@gmail.com

Overall Officials

Name	Affiliation	Role
mohamed A nady, lecturer	Assuit university hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut University Hospitals	Recruiting	Asyut			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided