Outcomes of Surgery of Aortic Valve | NCT04277572

Studies
Outcomes of Surgery of Aortic Valve

NCT04277572

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Feb 20, 2020Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Aortic Valve Disease

Interventions

Aortic valve replacement

Countries

Not provided

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

Feb 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2020Estimated

Primary Completion Date

Feb 28, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Feb 17, 2020

First Submission Date that Met QC Criteria

Feb 19, 2020

First Posted Date

Feb 20, 2020Actual

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

Feb 19, 2020

Last Update Posted Date

Feb 20, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Overall Goal: To study the outcomes of patients undergoing aortic valve surgeries, different approaches such as standard aortic valve replacement, aortic valve repair, novel techniques as Ozaki's procedure and their subsequent results and complications.

Objective 1: Identify predictors of complications following different types of aortic valve surgery accordingly.
Objective 2: Determine the value of each type in terms of advantages and disadvantages.
Objective3: Assess outcomes such as postoperative life expectancy, hospital stay, prognosis and quality of life.

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aortic valve replacement		using different ways of aortic valve replacement either by prosthetic valves or by ozaki technique	Procedure: Aortic valve replacement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aortic valve replacement	Procedure	Aortic valve surgery	Aortic valve replacement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Outcomes of different techniques of aortic valve surgery in the indicated patients for each type of surgery such as :	Number of days of postoperative hospital stay.	Up to one week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with severe symptomatic aortic valve lesion.
Asymptomatic aortic insufficiency patients with left ventricular dysfunction or significant left ventricular dilatation (LV end diastolic diameter>70 mm or LV end systolic diameter>50 mm.
Patients with aortic regurgitation caused by:
- a dilated aortic annulus
- conjoined cusp prolapse in bicuspid aortic valves (BAV)
- single cusp prolapse in tricuspid aortic valves
- aortic valve cusp perforation from endocarditis

Exclusion Criteria:

Patients with previous aortic root or valve 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

All patients registered in cardiac surgery department database, and who meet the listed inclusion and exclusion criteria will be eligible for the study.

Sampling Method

Non-Probability Sample

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

Condition Browse Module

MeSH Terms

ID	Term
D000082862	Aortic Valve Disease

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D065467	Transcatheter Aortic Valve Replacement

Ancestor Terms

ID	Term
D019918	Heart Valve Prosthesis Implantation
D006348	Cardiac Surgical Procedures
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided