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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.
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 Although the first generation pericardial valves were withdrawn from the market due to poor durability, further research has indicated that structural failure of early pericardial valves was due to tissue preparation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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitroflow Aortic Heart Valve | Device | Replacement of the native aortic valve or a previously implanted prosthetic aortic valve |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Aortic Valve Regurgitation | Measure the level of aortic insufficiency (severity of backflow) in the Mitroflow valve. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Onxley | Sorin Group USA, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Good Samaritan | Phoenix | Arizona | 85006 | United States | ||
| The University of Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8328836 | Background | 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. | |
| 3974271 | 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. |
| Label | URL |
|---|---|
| Click here for more information about Mitroflow | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mitroflow Aortic Pericardial Valve | Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Tucson |
| Arizona |
| 85724 |
| United States |
| Sharp Memorial Hospital | San Diego | California | 92123 | United States |
| Methodist Hospital | Indianapolis | Indiana | 46206 | United States |
| Heart Center of Indiana | Indianapolis | Indiana | 46240 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| St. Joseph's Medical Center | Towson | Maryland | 21204 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| St. Luke's Hospital | Kansas City | Missouri | 53215 | United States |
| Saint Michael's Med. Center | Newark | New Jersey | 07102 | United States |
| Newark Beth Israel Med Ctr | Newark | New Jersey | 07112 | United States |
| Westchester County Med Ctr | Valhalla | New York | 10595 | United States |
| Providence St. Vincent | Portland | Oregon | 97225 | United States |
| Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Hospital of the Univ. of PA | Philadelphia | Pennsylvania | 19104 | United States |
| Lankenau Hospital | Wynnewood | Pennsylvania | 19096 | United States |
| Baylor Univ. Medical Center | Dallas | Texas | 75246 | United States |
| Denton Regional Medical | Denton | Texas | 76210 | United States |
| Medical Center of Plano | Plano | Texas | 75075 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| Foothills Medical Centre | Calgary | Alberta | T2N 2T9 | Canada |
| Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia | B3H 3A7 | Canada |
| Sunnybrook and Women's College Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | Canada |
| Hopital Laval | Québec | Quebec | G1V 4G5 | Canada |
| 10678383 | 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. |
| 8041169 | 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. |
| 1562925 | 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. |
| 8328843 | 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. |
| 7646177 | 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. |
| 7582152 | 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. |
| 7646178 | 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. |
| 10064343 | 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. |
| 9930417 | 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. |
| 3512921 | 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. |
| 8162217 | 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. |
| 8800159 | 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. |
| Study Cohort |
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| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mitroflow Aortic Pericardial Valve | Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Cumulative follow-up in years occurring post 30 days | Posted | Mean | 95% Confidence Interval | Percent occurrence per patient-year | Late postoperative | patient-years | Participants |
|
|
| |||||||||||||||||||||||||||||||||||
| 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. | Patients with 12 month hemodynamic evaluations | Posted | Mean | Standard Deviation | mmHg | 12 months |
|
| ||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | cm^2 | 12 months |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Aortic Valve Regurgitation | Measure the level of aortic insufficiency (severity of backflow) in the Mitroflow valve. | Posted | Number | Percent of participants | 12 months |
|
|
All postop serious adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mitroflow Aortic Pericardial Valve | Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol. | 351 | 699 | 430 | 699 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Bleeding | Vascular disorders | Systematic Assessment |
| ||
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac arrhythmias | Cardiac disorders | Systematic Assessment |
| ||
| Endocarditis | Infections and infestations | Systematic Assessment |
| ||
| GI bleeding | Gastrointestinal disorders | Systematic Assessment |
| ||
| GI infection | Gastrointestinal disorders | Systematic Assessment |
| ||
| Heart failure | Cardiac disorders | Systematic Assessment |
| ||
| Hemic & Lymphatic | Blood and lymphatic system disorders | Systematic Assessment |
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| Metabolic & Nutritional | Metabolism and nutrition disorders | Systematic Assessment |
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| Miscellaneous GI disorders | Gastrointestinal disorders | Systematic Assessment |
| ||
| Miscellaneous infections | Infections and infestations | Systematic Assessment |
| ||
| Musculo-skeletal disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Nervous system | Nervous system disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Renal failure / insufficiency | Renal and urinary disorders | Systematic Assessment |
| ||
| Respiratory failure / disorder | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory infections | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sepsis / bacteremia | Infections and infestations | Systematic Assessment |
| ||
| Thromboembolic events | Vascular disorders | Systematic Assessment |
| ||
| UTI | Renal and urinary disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmias | Cardiac disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Heart failure | Cardiac disorders | Systematic Assessment |
| ||
| Miscellaneous infections | Infections and infestations | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Renal failure / insufficiency | Renal and urinary disorders | Systematic Assessment |
| ||
| Respiratory infections | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical and Medical Affairs | Sorin Group USA | 512-435-3602 | barbara.mathews@sorin.com |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D001022 | Aortic Valve Insufficiency |
| D001018 | Aortic Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000082862 | Aortic Valve Disease |
| D014652 | Vascular Diseases |
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| Title | Measurements |
|---|---|
|
| Major anticoagulant-related bleeding |
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| Thromboembolism |
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| Major thromboembolic event |
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| Valve thrombosis |
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| Endocarditis |
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| Non-structural valve dysfunction |
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| Perivalvular leak |
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| Hemolysis |
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| Valve reoperation |
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| Valve explant |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Valve Size 19 |
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| Valve Size 21 |
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| Valve Size 23 |
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| Valve Size 25 |
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| Valve Size 27 |
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| Valve Size 29 |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Valve Size 19 |
| |||||
| Valve Size 21 |
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| Valve Size 23 |
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| Valve Size 25 |
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| Valve Size 27 |
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| Valve Size 29 |
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| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| None |
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| Trace |
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| Mild |
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| Moderate |
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| Severe |
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