Outcomes of Surgery of Aortic Valve

Aortic Valve Disease Clinical Trial

— Aortic Surgery  

Official title:

Outcomes of Different Modalities for Surgery of Aortic Valve

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04277572
• Other study ID #: 17200395
• Status: Not yet recruiting
• Start date: March 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Disease

Intervention

Procedure:
• Aortic valve replacement
Aortic valve surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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