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Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve

NCT ID: NCT00630916

Last Updated: 2011-09-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

756 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2007-12-31

Brief Summary

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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

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 Although the first generation pericardial valves were withdrawn from the market due to poor durability, further research has indicated that structural failure of early pericardial valves was due to tissue preparation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

Conditions

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Heart Valve Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type NO_INTERVENTION

Mitroflow Aortic Heart Valve

Intervention Type DEVICE

Replacement of the native aortic valve or a previously implanted prosthetic aortic valve

Interventions

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Mitroflow Aortic Heart Valve

Replacement of the native aortic valve or a previously implanted prosthetic aortic valve

Intervention Type DEVICE

Other Intervention Names

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Mitroflow

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sorin Group USA, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mary Onxley

Role: STUDY_DIRECTOR

Sorin Group USA, Inc.

Locations

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Banner Good Samaritan

Phoenix, Arizona, United States

Site Status

The University of Arizona

Tucson, Arizona, United States

Site Status

Sharp Memorial Hospital

San Diego, California, United States

Site Status

Methodist Hospital

Indianapolis, Indiana, United States

Site Status

Heart Center of Indiana

Indianapolis, Indiana, United States

Site Status

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

St. Joseph's Medical Center

Towson, Maryland, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

St. Luke's Hospital

Kansas City, Missouri, United States

Site Status

Saint Michael's Med. Center

Newark, New Jersey, United States

Site Status

Newark Beth Israel Med Ctr

Newark, New Jersey, United States

Site Status

Westchester County Med Ctr

Valhalla, New York, United States

Site Status

Providence St. Vincent

Portland, Oregon, United States

Site Status

Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Hospital of the Univ. of PA

Philadelphia, Pennsylvania, United States

Site Status

Lankenau Hospital

Wynnewood, Pennsylvania, United States

Site Status

Baylor Univ. Medical Center

Dallas, Texas, United States

Site Status

Denton Regional Medical

Denton, Texas, United States

Site Status

Medical Center of Plano

Plano, Texas, United States

Site Status

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Site Status

St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Site Status

Foothills Medical Centre

Calgary, Alberta, Canada

Site Status

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Site Status

Sunnybrook and Women's College Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Montreal Heart Institute

Montreal, Quebec, Canada

Site Status

Hopital Laval

Québec, Quebec, Canada

Site Status

Countries

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United States Canada

References

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Duran CM. Pericardium in valve operations. Ann Thorac Surg. 1993 Jul;56(1):1-2. doi: 10.1016/0003-4975(93)90393-v. No abstract available.

Reference Type BACKGROUND
PMID: 8328836 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3974271 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10678383 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8041169 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1562925 (View on PubMed)

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. doi: 10.1016/0003-4975(93)90416-f.

Reference Type BACKGROUND
PMID: 8328843 (View on PubMed)

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. doi: 10.1016/0003-4975(95)00222-7.

Reference Type BACKGROUND
PMID: 7646177 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7582152 (View on PubMed)

Pomar JL, Jamieson WR, Pelletier LC, Gerein AN, Castella M, Brownlee RT. Mitroflow pericardial bioprosthesis: clinical performance to ten years. Ann Thorac Surg. 1995 Aug;60(2 Suppl):S305-9; discussion S309-10. doi: 10.1016/0003-4975(95)00307-7.

Reference Type BACKGROUND
PMID: 7646178 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10064343 (View on PubMed)

Pomar JL, Jamieson WR, Pelletier LC, Castella 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. doi: 10.1016/s0003-4975(98)01129-1.

Reference Type BACKGROUND
PMID: 9930417 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 3512921 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8162217 (View on PubMed)

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. doi: 10.1016/s0022-5223(96)70055-7. No abstract available.

Reference Type BACKGROUND
PMID: 8800159 (View on PubMed)

Related Links

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http://www.sorin.com/eng/index.asp

Click here for more information about Mitroflow

Other Identifiers

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SYNPCR-01

Identifier Type: -

Identifier Source: org_study_id