Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00630916
Recruitment Status : Completed
First Posted : March 7, 2008
Results First Posted : September 20, 2011
Last Update Posted : September 22, 2011
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Heart Valve Diseases Device: Mitroflow Aortic Heart Valve Not Applicable

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 Although the first generation pericardial valves were withdrawn from the market due to poor durability, further research has indicated that structural failure of early pericardial valves was due to tissue preparation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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 756 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve
Study Start Date : November 2003
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: A Device: Mitroflow Aortic Heart Valve
Replacement of the native aortic valve or a previously implanted prosthetic aortic valve
Other Name: Mitroflow

Primary Outcome Measures :
  1. Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair [ Time Frame: 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.

  2. Mean Gradient [ Time Frame: 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.

  3. Effective Orifice Area [ Time Frame: 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 :
  1. Aortic Valve Regurgitation [ Time Frame: 12 months ]
    Measure the level of aortic insufficiency (severity of backflow) in the Mitroflow valve.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00630916

  Hide Study Locations
United States, Arizona
Banner Good Samaritan
Phoenix, Arizona, United States, 85006
The University of Arizona
Tucson, Arizona, United States, 85724
United States, California
Sharp Memorial Hospital
San Diego, California, United States, 92123
United States, Indiana
Methodist Hospital
Indianapolis, Indiana, United States, 46206
Heart Center of Indiana
Indianapolis, Indiana, United States, 46240
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
St. Joseph's Medical Center
Towson, Maryland, United States, 21204
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
St. Luke's Hospital
Kansas City, Missouri, United States, 53215
United States, New Jersey
Saint Michael's Med. Center
Newark, New Jersey, United States, 07102
Newark Beth Israel Med Ctr
Newark, New Jersey, United States, 07112
United States, New York
Westchester County Med Ctr
Valhalla, New York, United States, 10595
United States, Oregon
Providence St. Vincent
Portland, Oregon, United States, 97225
United States, Pennsylvania
Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Hospital of the Univ. of PA
Philadelphia, Pennsylvania, United States, 19104
Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
United States, Texas
Baylor Univ. Medical Center
Dallas, Texas, United States, 75246
Denton Regional Medical
Denton, Texas, United States, 76210
Medical Center of Plano
Plano, Texas, United States, 75075
United States, Virginia
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
United States, Wisconsin
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Sunnybrook and Women's College Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Hopital Laval
Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Sorin Group USA, Inc.
Study Director: Mary Onxley Sorin Group USA, Inc.

Additional Information:

Responsible Party: Sorin Group USA, Inc. Identifier: NCT00630916     History of Changes
Other Study ID Numbers: SYNPCR-01
First Posted: March 7, 2008    Key Record Dates
Results First Posted: September 20, 2011
Last Update Posted: September 22, 2011
Last Verified: September 2011

Keywords provided by Sorin Group USA, Inc.:
Aortic valve insufficiency
Aortic valve
Aortic disease
Aortic incompetence

Additional relevant MeSH terms:
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases