Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve - Full Text View

Purpose

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	Intervention
Heart Valve Diseases	Device: Mitroflow Aortic Heart Valve

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve

Resource links provided by NLM:

MedlinePlus related topics: Heart Valve Diseases

U.S. FDA Resources

Further study details as provided by Sorin Group USA, Inc.:

Primary Outcome Measures:

Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair [ Time Frame: Late postoperative ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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:

Aortic Valve Regurgitation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Measure the level of aortic insufficiency (severity of backflow) in the Mitroflow valve.

Enrollment:	756
Study Start Date:	November 2003
Study Completion Date:	December 2007
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: A	Device: Mitroflow Aortic Heart Valve Replacement of the native aortic valve or a previously implanted prosthetic aortic valve Other Name: Mitroflow

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630916

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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
Heart Center of Indiana
Indianapolis, Indiana, United States, 46240
Methodist Hospital
Indianapolis, Indiana, United States, 46206
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
Newark Beth Israel Med Ctr
Newark, New Jersey, United States, 07112
Saint Michael's Med. Center
Newark, New Jersey, United States, 07102
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
Canada
Hopital Laval
Quebec, Canada, G1V 4G5

Sponsors and Collaborators

Sorin Group USA, Inc.

Investigators

Study Director:

Mary Onxley

Sorin Group USA, Inc.

More Information

Publications:

Duran CM. Pericardium in valve operations. Ann Thorac Surg. 1993 Jul;56(1):1-2. No abstract available.

Cosgrove DM, Lytle BW, Gill CC, Golding LA, Stewart RW, Loop FD, Williams GW. In vivo hemodynamic comparison of porcine and pericardial valves. J Thorac Cardiovasc Surg. 1985 Mar;89(3):358-68.

Minami K, Boethig D, Mirow N, Kleikamp G, Koertke H, Godehardt E, Koerfer R. Mitroflow pericardial valve prosthesis in the aortic position: an analysis of long-term outcome and prognostic factors. J Heart Valve Dis. 2000 Jan;9(1):112-22.

Moggio RA, Pooley RW, Sarabu MR, Christiana J, Ho AW, Reed GE. Experience with the Mitroflow aortic bioprosthesis. J Thorac Cardiovasc Surg. 1994 Aug;108(2):215-20.

Jamieson WR, Pelletier LC, Gerein AN, Pomar J. The Mitroflow pericardial bioprosthesis. Comparison of early clinical performance in aortic and mitral positions. Can J Surg. 1992 Apr;35(2):159-64.

Loisance DY, Mazzucotelli JP, Bertrand PC, Deleuze PH, Cachera JP. Mitroflow pericardial valve: long-term durability. Ann Thorac Surg. 1993 Jul;56(1):131-6.

Mazzucotelli JP, Bertrand PC, Loisance DY. Durability of the Mitroflow pericardial valve at ten years. Ann Thorac Surg. 1995 Aug;60(2 Suppl):S303-4.

Mazzucotelli JP, Bertrand PC, Loisance DY. The Mitroflow pericardial valve: clinical performance to 10 years. J Heart Valve Dis. 1995 Jul;4(4):407-13.

Pomar JL, Jamieson WR, Pelletier LC, Gerein AN, Castellá M, Brownlee RT. Mitroflow pericardial bioprosthesis: clinical performance to ten years. Ann Thorac Surg. 1995 Aug;60(2 Suppl):S305-9; discussion S309-10.

Reber D, Birnbaum DE, Tollenaere P, Eschenbruch E. Long-term results after aortic valve replacement with the Mitroflow pericardial valve. J Cardiovasc Surg (Torino). 1996 Dec;37(6 Suppl 1):23-7.

Pomar JL, Jamieson WR, Pelletier LC, Castellá M, Germann E, Brownlee RT. Mitroflow pericardial bioprosthesis experience in aortic valve replacement > or =60 years of age. Ann Thorac Surg. 1998 Dec;66(6 Suppl):S53-6.

Gersh BJ, Fisher LD, Schaff HV, Rahimtoola SH, Reeder GS, Frater RW, McGoon DC. Issues concerning the clinical evaluation of new prosthetic valves. J Thorac Cardiovasc Surg. 1986 Mar;91(3):460-6. Review. No abstract available.

Grunkemeier GL, Johnson DM, Naftel DC. Sample size requirements for evaluating heart valves with constant risk events. J Heart Valve Dis. 1994 Jan;3(1):53-8.

Edmunds LH Jr, Clark RE, Cohn LH, Grunkemeier GL, Miller DC, Weisel RD. Guidelines for reporting morbidity and mortality after cardiac valvular operations. Ad Hoc Liaison Committee for Standardizing Definitions of Prosthetic Heart Valve Morbidity of The American Association for Thoracic Surgery and The Society of Thoracic Surgeons. J Thorac Cardiovasc Surg. 1996 Sep;112(3):708-11. No abstract available.

Responsible Party:	Sorin Group USA, Inc.
ClinicalTrials.gov Identifier:	NCT00630916 History of Changes
Other Study ID Numbers:	SYNPCR-01
Study First Received:	February 28, 2008
Results First Received:	July 8, 2011
Last Updated:	September 20, 2011
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013