An observational study in Aortic Valve Disease, sponsored by Assiut University. Status unknown. Per ClinicalTrials.gov, last updated 2022-02-07.
Sponsored by Assiut University · Observational
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.
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.
231 studies on the registry are indexed under Aortic Valve Disease; 76 are open to participants now.
This study's planned enrollment of 100 is below the median of 200 across 112 observational studies indexed under Aortic Valve Disease.
Browse Aortic Valve Disease studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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
Exclusion Criteria:
simple procedure but need long term of anticoagulant
Procedure: Aortic valve surgery
complicated procedure but without anticoagulant
Procedure: Aortic valve surgery
mechanical aortic valve replacement versus ross procedure and stentless bioprothesis
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
Time frame: baseline
No study locations are listed for this record.
This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Assiut University