Outcomes of Surgery of Aortic Valve

NCT04277572 | Unknown DMC

• 1 other identifier: 17200395
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aortic Valve Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Aortic valve replacement

using different ways of aortic valve replacement either by prosthetic valves or by ozaki technique

Procedure: Aortic valve replacement

Interventions

Aortic valve replacement PROCEDURE

Aortic valve surgery

Also known as: Ozaki procedure

Aortic valve replacement

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Patients with previous aortic root or valve surgery.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Aortic Valve Disease

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 20, 2020
• Study Start: March 1, 2020
• Primary Completion: February 28, 2022
• Study Completion: December 31, 2022
• Last Updated: February 20, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share