Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sorin Group USA, Inc.
ClinicalTrials.gov Identifier:
NCT00630916
First received: February 28, 2008
Last updated: September 20, 2011
Last verified: September 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 26 Study Locations
Sponsors and Collaborators
Sorin Group USA, Inc.
Investigators
Study Director: Mary Onxley Sorin Group USA, Inc.
  More Information

Publications:

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 July 29, 2014