Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve

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.

Study Overview

• Status: Completed
• Conditions: Heart Valve Diseases
• Intervention / Treatment: Device: Mitroflow Aortic Heart Valve

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 Although the first generation pericardial valves were withdrawn from the market due to poor durability, further research has indicated that structural failure of early pericardial valves was due to tissue preparation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
• Enrollment (Actual): 756
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Mitroflow

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aortic Valve Regurgitation	Measure the level of aortic insufficiency (severity of backflow) in the Mitroflow valve.	12 months

Collaborators and Investigators

• Sponsor: Sorin Group USA, Inc.
• Investigators: Study Director: Mary Onxley, Sorin Group USA, Inc.

Publications and helpful links

General Publications

• 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.
• 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. doi: 10.1016/0003-4975(93)90416-f.
• 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.
• 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, 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.
• 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, 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.
• 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.
• 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. doi: 10.1016/s0022-5223(96)70055-7. No abstract available.

Helpful Links

• Click here for more information about Mitroflow

Study record dates

Study Major Dates

• Study Start: November 1, 2003
• Primary Completion (ACTUAL): December 1, 2005
• Study Completion (ACTUAL): December 1, 2007

Study Registration Dates

• First Submitted: February 28, 2008
• First Submitted That Met QC Criteria: February 28, 2008
• First Posted (ESTIMATE): March 7, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): September 22, 2011
• Last Update Submitted That Met QC Criteria: September 20, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Aortic valve; Aortic disease; Aortic valve insufficiency; Aortic incompetence
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases
• Other Study ID Numbers: SYNPCR-01