Aortic Valve Replacement With Trifecta(TM)
Summary
To confirm the clinical safety and effectiveness of the Trifecta valve.
Description
The clinical investigation is a multi-center, multi-country, prospective, non-randomized, observational study designed to evaluate the safety and effectiveness of the Trifecta valve.
Study Design
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Aortic Valve Insufficiency
Intervention
Trifecta Aortic Heart Valve
Location
USC Keck School of Medicine, Dept. of Cardiothoracic Surgery, USC University Hospital
Los Angeles
California
United States
90033
Status
Active, not recruiting
Source
St. Jude Medical
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00475709
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Aortic Valve Insufficiency
Pathological condition characterized by the backflow of blood from the ASCENDING AORTA back into the LEFT VENTRICLE, leading to regurgitation. It is caused by diseases of the AORTIC VALVE or its surrounding tissue (aortic root).
Aortic Valve Prolapse
The downward displacement of the cuspal or pointed end of the trileaflet AORTIC VALVE causing misalignment of the cusps. Severe valve distortion can cause leakage and allow the backflow of blood from the ASCENDING AORTA back into the LEFT VENTRICLE, leading to aortic regurgitation.
Discrete Subaortic Stenosis
A type of constriction that is caused by the presence of a fibrous ring (discrete type) below the AORTIC VALVE, anywhere between the aortic valve and the MITRAL VALVE. It is characterized by restricted outflow from the LEFT VENTRICLE into the AORTA.
Aortic Valve Stenosis
A pathological constriction that can occur above (supravalvular stenosis), below (subvalvular stenosis), or at the AORTIC VALVE. It is characterized by restricted outflow from the LEFT VENTRICLE into the AORTA.
Syphilis, Cardiovascular
Cardiovascular manifestations of SYPHILIS, an infection of TREPONEMA PALLIDUM. In the late stage of syphilis, sometimes 20-30 years after the initial infection, damages are often seen in the blood vessels including the AORTA and the AORTIC VALVE. Clinical signs include syphilitic aortitis, aortic insufficiency, or aortic ANEURYSM.
Clinical Trials
Aortic Valve Replacement With Trifecta(TM)
The purpose of this study is to confirm the clinical safety and effectiveness of the Trifecta valve.
Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve
This is a trial to demonstrate the safety and effectiveness of the Mitroflow Aortic Heart Valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
Conservative Aortic Valve Surgery for Aortic Insufficiency and Aneurysms of the Aortic Root. CAVIAAR
The primary objective of the CAVIAAR study is to prove that aortic valve sparing is associated with a 50% increase of 3 years-survival rate without increased mortality or serious increased...
The purpose of this study is to determine if there is any difference in the counts of cerebral emboli and platelet function between two prophylactic treatments of thrombosis currently used...
Transapical Implantation of Ventor Embracer™ Valve in Patients With Severe Aortic Valve Disease
A prospective single arm study evaluating feasibility and safety of a catheter-based transapical implantation of the Ventor Embracer™ aortic valve bioprosthesis in patients with severe a...
PubMed Articles
Quadricuspid aortic valve by using intraoperative transesophageal echocardiography.
ABSTRACT: Quadricuspid aortic valve is a rare congenital malformation of the aortic valve. Its diagnosis is often missed even with the use of transthoracic echocardiogram. Many of these patients progr...
Original aortic valve plasty with autologous pericardium for quadricuspid valve.
Quadricuspid aortic valves represent a very rare pathology. Most cases have been discovered incidentally during heart operations or at autopsy. Patients may become symptomatic with aortic regurgitatio...
Surgical treatment of aortic valve disease.
The development of intraoperative transoesophageal echocardiography together with improved understanding of the functional anatomy of the aortic valve have allowed the design of several new conservati...
Surgery for Aortic Regurgitation due to Dehiscence of Aortic Valve Commissure.
A 74-year-old man underwent aortic valve replacement due to aortic regurgitation after two months of medication for congestive heart failure. At surgery, the cause of the aortic regurgitation appeared...
Described herein are two brothers, both with a congenitally bicuspid aortic valve-one of which was stenotic and one of which functioned normally-and one with associated aortic isthmic coarctation. Sum...
