Outcomes of Surgery of Aortic Valve (Aortic Surgery)

February 19, 2020 updated by: Ahmed Gamal Thabet Ahmed, Assiut University

Outcomes of Different Modalities for Surgery of Aortic Valve

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

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

Non-Probability Sample

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.

Description

Inclusion Criteria:

  1. Patients with severe symptomatic aortic valve lesion.
  2. 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.

  3. 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.

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
Aortic valve replacement
using different ways of aortic valve replacement either by prosthetic valves or by ozaki technique
Procedure: Aortic valve replacement
Aortic valve surgery
Other Names:
  • Ozaki procedure

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Assiut University

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 (Anticipated)

March 1, 2020

Primary Completion (Anticipated)

February 28, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

February 17, 2020

First Submitted That Met QC Criteria

February 19, 2020

First Posted (Actual)

February 20, 2020

Study Record Updates

Last Update Posted (Actual)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 19, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17200395

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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