Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve

NCT00630916 | Completed Results DMC

• 1 other identifier: SYNPCR-01
• Study Type: interventional
• Target: 756
• Locations: 2 countries
• Sites: 26

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.

Conditions

Heart Valve Diseases

Keywords

Aortic valve insufficiency; Aortic valve; Aortic disease; Aortic incompetence

Outcome Measures

Primary Outcomes (3)

• Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair

  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.

  Late postoperative

• Mean Gradient

  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.

  12 months

• Effective Orifice Area

  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.

  12 months

Secondary Outcomes (1)

• Aortic Valve Regurgitation

  12 months

Study Arms (1)

A

NO INTERVENTION

Device: Mitroflow Aortic Heart Valve

Interventions

Mitroflow Aortic Heart Valve DEVICE

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

Also known as: Mitroflow

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sorin Group USA, Inc.: lead

Study Sites (26)

Banner Good Samaritan

Phoenix, Arizona, 85006, United States

Location

The University of Arizona

Tucson, Arizona, 85724, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

Methodist Hospital

Indianapolis, Indiana, 46206, United States

Location

Heart Center of Indiana

Indianapolis, Indiana, 46240, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

St. Joseph's Medical Center

Towson, Maryland, 21204, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

St. Luke's Hospital

Kansas City, Missouri, 53215, United States

Location

Saint Michael's Med. Center

Newark, New Jersey, 07102, United States

Location

Newark Beth Israel Med Ctr

Newark, New Jersey, 07112, United States

Location

Westchester County Med Ctr

Valhalla, New York, 10595, United States

Location

Providence St. Vincent

Portland, Oregon, 97225, United States

Location

Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Hospital of the Univ. of PA

Philadelphia, Pennsylvania, 19104, United States

Location

Lankenau Hospital

Wynnewood, Pennsylvania, 19096, United States

Location

Baylor Univ. Medical Center

Dallas, Texas, 75246, United States

Location

Denton Regional Medical

Denton, Texas, 76210, United States

Location

Medical Center of Plano

Plano, Texas, 75075, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Sunnybrook and Women's College Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Hopital Laval

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (14)

• 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.

  PMID: 8328836 BACKGROUND

• 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.

  PMID: 3974271 BACKGROUND

• 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.

  PMID: 10678383 BACKGROUND

• 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.

  PMID: 8041169 BACKGROUND

• 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.

  PMID: 1562925 BACKGROUND

• 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.

  PMID: 8328843 BACKGROUND

• 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.

  PMID: 7646177 BACKGROUND

• 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.

  PMID: 7582152 BACKGROUND

• 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.

  PMID: 7646178 BACKGROUND

• 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.

  PMID: 10064343 BACKGROUND

• 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.

  PMID: 9930417 BACKGROUND

• 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.

  PMID: 3512921 BACKGROUND

• 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.

  PMID: 8162217 BACKGROUND

• 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.

  PMID: 8800159 BACKGROUND

Related Links

• Click here for more information about Mitroflow

MeSH Terms

Conditions

Heart Valve Diseases; Aortic Valve Insufficiency; Aortic Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Vascular Diseases

Results Point of Contact

• Title: Director of Clinical and Medical Affairs
• Organization: Sorin Group USA

barbara.mathews@sorin.com

512-435-3602

Study Officials

• Mary Onxley

  Sorin Group USA, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: March 7, 2008
• Study Start: November 1, 2003
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2007
• Last Updated: September 22, 2011
• Results First Posted: September 20, 2011

Record last verified: 2011-09

Locations

US (21); CA (5)