NCT05167539

Brief Summary

Each type of Aortic valve surgery has its advantages and disadvantages; we aim to differentiate between two types of aortic valve surgery: aortic root replacement (using either Ross procedure or stentless bioprosthesis procedure) and mechanical aortic valve replacement.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

February 10, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

February 7, 2022

Status Verified

January 1, 2022

Enrollment Period

2 years

First QC Date

December 20, 2021

Last Update Submit

January 23, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of participants with failure of surgery

    Number of participants with failure of initial intervention , Requiring a second intervention i.e redo aortic valve surgery

    baseline

Study Arms (2)

Mechanical aortic valve replacement

simple procedure but need long term of anticoagulant

Procedure: Aortic valve surgery

Aortic root replacement

complicated procedure but without anticoagulant

Procedure: Aortic valve surgery

Interventions

mechanical aortic valve replacement versus ross procedure and stentless bioprothesis

Aortic root replacementMechanical aortic valve replacement

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who presented to Cardiothoracic Surgery Department, Assiut University Heart Hospital and Aswan heart center who meet the listed inclusion will be eligible for the study. The charts will be reviewed and eligible patients will be filtered

You may qualify if:

  • Patients undergoing Aortic valve surgery.

You may not qualify if:

  • Patients who have other procedure with aortic valve surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Central Study Contacts

Ali Abdelraouf, Assistant lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

December 20, 2021

First Posted

December 22, 2021

Study Start

February 10, 2022

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

February 7, 2022

Record last verified: 2022-01