Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve
- Conditions
- Heart Valve Diseases
- Interventions
- Device: Mitroflow Aortic Heart Valve
- Registration Number
- NCT00630916
- Lead Sponsor
- Sorin Group USA, Inc.
- Brief Summary
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.
- Detailed Description
Bioprosthetic heart valves offer several advantages over mechanical valves, the most important being freedom from the need for anticoagulation and a low rate of thromboembolic events. Pericardial bioprosthetic valves are known to have hemodynamic performance superior to porcine valves, and the excellent hemodynamic performance of pericardial valves is particularly relevant in patients with a small aortic root. However, long-term durability continues to be the main concern with use of pericardial valves. Although the first generation pericardial valves were withdrawn from the market due to poor durability, further research has indicated that structural failure of early pericardial valves was due to tissue preparation techniques and design failure rather than the pericardial tissue.The unique desing of the Mitroflow Aortic Heart Valve may provide superior hemodynamic performance over other tissue valves.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 756
- The subject is male or female 18 years old or older
- The subject or subject's legal representative is willing to sign the informed consent
- A bioprosthesis is the most suitable alternative for replacement of a dysfunctional or diseased native aortic valve or prosthesis accord gin to the current medical practice for valve selection at the center
- The subject is able to return for all follow-up evaluations for the duration of the study (i.e. geographically stable
- The patient has preexisting valve prosthesis in the mitral, pulmonary or tricuspid position
- The patient requires a double or triple valve replacement
- The patient had a Mitroflow Heart valve during the clinical study but who then had the valve explanted
- The patient has active endocarditis
- The subject is or will be participating in a concomitant research study of an investigational product
- The subject is a minor, intravenous drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent
- The patient has a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy of less than 1 year, or the implant of the device produces an unacceptable increased risk to the patient the patient is pregnant or lactating
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A Mitroflow Aortic Heart Valve -
- Primary Outcome Measures
Name Time Method Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair Late postoperative Hazard rate calculated as the number of adverse events divided by the total follow-up in years. Calculation is based on cumulative events and follow-up occurring \>30 days after valve implant.
Mean Gradient 12 months Mean pressure across the Mitroflow aortic pericardial valve measured via echocardiography to assess ease of blood flow through the prosthetic valve for each valve size.
Effective Orifice Area 12 months Effective orifice area of the Mitroflow pericardial aortic valve measured via echocardiography to assess physiological area of blood flow through the prosthetic valve for each valve size.
- Secondary Outcome Measures
Name Time Method Aortic Valve Regurgitation 12 months Measure the level of aortic insufficiency (severity of backflow) in the Mitroflow valve.
Trial Locations
- Locations (26)
Baylor Univ. Medical Center
🇺🇸Dallas, Texas, United States
Banner Good Samaritan
🇺🇸Phoenix, Arizona, United States
Montreal Heart Institute
🇨🇦Montreal, Quebec, Canada
Denton Regional Medical
🇺🇸Denton, Texas, United States
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
The University of Arizona
🇺🇸Tucson, Arizona, United States
Saint Michael's Med. Center
🇺🇸Newark, New Jersey, United States
Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
Heart Center of Indiana
🇺🇸Indianapolis, Indiana, United States
Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
St. Joseph's Medical Center
🇺🇸Towson, Maryland, United States
St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
St. Luke's Hospital
🇺🇸Kansas City, Missouri, United States
Hopital Laval
🇨🇦Quebec, Canada
Westchester County Med Ctr
🇺🇸Valhalla, New York, United States
Hospital of the Univ. of PA
🇺🇸Philadelphia, Pennsylvania, United States
Providence St. Vincent
🇺🇸Portland, Oregon, United States
Medical Center of Plano
🇺🇸Plano, Texas, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Newark Beth Israel Med Ctr
🇺🇸Newark, New Jersey, United States
Lankenau Hospital
🇺🇸Wynnewood, Pennsylvania, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Sunnybrook and Women's College Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
Queen Elizabeth II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada