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Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve

Primary Purpose

Heart Valve Diseases

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Mitroflow Aortic Heart Valve
Sponsored by
Sorin Group USA, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Valve Diseases focused on measuring Aortic valve insufficiency, Aortic valve, Aortic disease, Aortic incompetence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Banner Good Samaritan
  • The University of Arizona
  • Sharp Memorial Hospital
  • Methodist Hospital
  • Heart Center of Indiana
  • Johns Hopkins Hospital
  • St. Joseph's Medical Center
  • Mayo Clinic
  • St. Luke's Hospital
  • Saint Michael's Med. Center
  • Newark Beth Israel Med Ctr
  • Westchester County Med Ctr
  • Providence St. Vincent
  • Hershey Medical Center
  • Hospital of the Univ. of PA
  • Lankenau Hospital
  • Baylor Univ. Medical Center
  • Denton Regional Medical
  • Medical Center of Plano
  • Sentara Norfolk General Hospital
  • St. Luke's Medical Center
  • Foothills Medical Centre
  • Queen Elizabeth II Health Sciences Centre
  • Sunnybrook and Women's College Health Sciences Centre
  • Montreal Heart Institute
  • Hopital Laval

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

A

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Aortic Valve Regurgitation
Measure the level of aortic insufficiency (severity of backflow) in the Mitroflow valve.

Full Information

First Posted
February 28, 2008
Last Updated
September 20, 2011
Sponsor
Sorin Group USA, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00630916
Brief Title
Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve
Official Title
Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorin Group USA, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Valve Diseases
Keywords
Aortic valve insufficiency, Aortic valve, Aortic disease, Aortic incompetence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
756 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Mitroflow Aortic Heart Valve
Other Intervention Name(s)
Mitroflow
Intervention Description
Replacement of the native aortic valve or a previously implanted prosthetic aortic valve
Primary Outcome Measure Information:
Title
Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair
Description
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.
Time Frame
Late postoperative
Title
Mean Gradient
Description
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.
Time Frame
12 months
Title
Effective Orifice Area
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Aortic Valve Regurgitation
Description
Measure the level of aortic insufficiency (severity of backflow) in the Mitroflow valve.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Onxley
Organizational Affiliation
Sorin Group USA, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Banner Good Samaritan
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
The University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46206
Country
United States
Facility Name
Heart Center of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46240
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
St. Joseph's Medical Center
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
St. Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
53215
Country
United States
Facility Name
Saint Michael's Med. Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
Newark Beth Israel Med Ctr
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
Westchester County Med Ctr
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Providence St. Vincent
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Hospital of the Univ. of PA
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Lankenau Hospital
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Baylor Univ. Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Denton Regional Medical
City
Denton
State/Province
Texas
ZIP/Postal Code
76210
Country
United States
Facility Name
Medical Center of Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Sunnybrook and Women's College Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Hopital Laval
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
8328836
Citation
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.
Results Reference
background
PubMed Identifier
3974271
Citation
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.
Results Reference
background
PubMed Identifier
10678383
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.
Results Reference
background
PubMed Identifier
8041169
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.
Results Reference
background
PubMed Identifier
1562925
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.
Results Reference
background
PubMed Identifier
8328843
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. doi: 10.1016/0003-4975(93)90416-f.
Results Reference
background
PubMed Identifier
7646177
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. doi: 10.1016/0003-4975(95)00222-7.
Results Reference
background
PubMed Identifier
7582152
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.
Results Reference
background
PubMed Identifier
7646178
Citation
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.
Results Reference
background
PubMed Identifier
10064343
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.
Results Reference
background
PubMed Identifier
9930417
Citation
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.
Results Reference
background
PubMed Identifier
3512921
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. No abstract available.
Results Reference
background
PubMed Identifier
8162217
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.
Results Reference
background
PubMed Identifier
8800159
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. doi: 10.1016/s0022-5223(96)70055-7. No abstract available.
Results Reference
background
Links:
URL
http://www.sorin.com/eng/index.asp
Description
Click here for more information about Mitroflow

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Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve

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