Aortic Root Enlargement Versus Aortic Root Replacement in the Management of Cases With Small Aortic Root

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05167539
Collaborator
(none)
100
23.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Aortic valve surgery

Detailed Description

Aortic valve replacement has been performed since the 1950s. Since then, the surgical procedure has been optimized to reduce the risk of procedure-related complications. In addition, technical advances in the design of valves have significantly improved long-term prognosis. After the initial use of mechanical ball-caged valves, numerous monoleaflet and bileaflet valves have been introduced and evaluated. Moreover, bioprosthetic valves came on the market in the 1960s as an alternative to mechanical valve.

The pulmonary autograft was introduced in clinical practice as a substitute for the diseased aortic valve by Donald Ross in 1967. The original implant technique, namely subcoronary freehand grafting, was associated with substantial prevalence of early and late valve dysfunction, thereby limiting widespread adoption of the operation. More recent experience with pulmonary autografts used for complete or partial aortic root replacement allowed for satisfactory functional behavior of the valve .

Homografts for aortic valve replacement were the first biologic stentless prostheses used in clinical practice in the 1960s. Binet introduced a stentless porcine bioprosthesis, but the valve was abandoned because of poor tissue fixation. Due to limited availability and a relatively difficult implantation technique, mechanical AVR became the popular therapeutic option. The disadvantage of life-long anticoagulation therapy in mechanical AVR prompted the development of xenogeneic bioprostheses. Although porcine aortic valves or pericardial tissue mounted on a stent made the implantation technique easier, these valves sacrificed orifice area and increased stress at the attachment of the stent, which caused earlier primary tissue failure. Optimizing hemodynamics to prevent patient-prosthetic mismatch and improve durability revived the use of stentless bioprostheses in the early 1990s.

Patients with an expected survival of less than 10 years (more than 65 years old, renal disease, lung disease, patients who are more than 60 years old), ejection fraction of less than 40%, or coronary disease would be reasonable candidates for aortic bioprostheses to avoid anticoagulation with an extremely low likelihood of aortic valve reoperation. Results tend to favor mechanical aortic valves in patients under age 65 years with a life expectancy of at least 10 years.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Aortic Root Enlargement Versus Aortic Root Replacement in the Management of Cases With Small Aortic Root
Anticipated Study Start Date :
Feb 10, 2022
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Mechanical aortic valve replacement

simple procedure but need long term of anticoagulant

Procedure: Aortic valve surgery
mechanical aortic valve replacement versus ross procedure and stentless bioprothesis

Aortic root replacement

complicated procedure but without anticoagulant

Procedure: Aortic valve surgery
mechanical aortic valve replacement versus ross procedure and stentless bioprothesis

Outcome Measures

Primary Outcome Measures

  1. Number of participants with failure of surgery [baseline]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients undergoing Aortic valve surgery.
Exclusion Criteria:
  • Patients who have other procedure with aortic valve surgery.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ali Mohamed Abdelraouf, Assistant Lecturer, Assiut University
ClinicalTrials.gov Identifier:
NCT05167539
Other Study ID Numbers:
  • Aortic valve surgery
First Posted:
Dec 22, 2021
Last Update Posted:
Feb 7, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 7, 2022