Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve

Heart Valve Diseases Clinical Trial

Official title:

Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00630916
• Other study ID #: SYNPCR-01
• Status: Completed
• Phase: N/A
• First received: February 28, 2008
• Last updated: September 20, 2011
• Start date: November 2003
• Est. completion date: December 2007

Study information

• Verified date: September 2011
• Source: Sorin Group USA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 Although the first generation pericardial valves were withdrawn from the market due to poor durability, further research has indicated that structural failure of early pericardial valves was due to tissue preparation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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 756
• Est. completion date: December 2007
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Valve Diseases

Intervention

Device:
• Mitroflow Aortic Heart Valve
Replacement of the native aortic valve or a previously implanted prosthetic aortic valve

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Hopital Laval	Quebec
Canada	Sunnybrook and Women's College Health Sciences Centre	Toronto	Ontario
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Baylor Univ. Medical Center	Dallas	Texas
United States	Denton Regional Medical	Denton	Texas
United States	Hershey Medical Center	Hershey	Pennsylvania
United States	Heart Center of Indiana	Indianapolis	Indiana
United States	Methodist Hospital	Indianapolis	Indiana
United States	St. Luke's Hospital	Kansas City	Missouri
United States	St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Newark Beth Israel Med Ctr	Newark	New Jersey
United States	Saint Michael's Med. Center	Newark	New Jersey
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Hospital of the Univ. of PA	Philadelphia	Pennsylvania
United States	Banner Good Samaritan	Phoenix	Arizona
United States	Medical Center of Plano	Plano	Texas
United States	Providence St. Vincent	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	Sharp Memorial Hospital	San Diego	California
United States	St. Joseph's Medical Center	Towson	Maryland
United States	The University of Arizona	Tucson	Arizona
United States	Westchester County Med Ctr	Valhalla	New York
United States	Lankenau Hospital	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sorin Group USA, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (14)

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. — View Citation

Duran CM. Pericardium in valve operations. Ann Thorac Surg. 1993 Jul;56(1):1-2. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No
Primary	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	No
Secondary	Aortic Valve Regurgitation	Measure the level of aortic insufficiency (severity of backflow) in the Mitroflow valve.	12 months	No

External Links

•   Click here for more information about Mitroflow