An interventional study of Mitroflow Aortic Heart Valve in Heart Valve Diseases, sponsored by Sorin Group USA, Inc.. Completed at 26 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-09-22.
Sponsored by Sorin Group USA, Inc. · Not applicable, Interventional, and Treatment
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 Although the first generation pericardial valves were withdrawn from the market due to poor durability, further research has indicated that structural failure of early pericardial valves was due to tissue preparation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.
535 studies on the registry are indexed under Heart Valve Diseases; 173 are open to participants now.
This study's enrollment of 756 is above the median of 100 across 291 interventional studies indexed under Heart Valve Diseases.
Browse Heart Valve Diseases studies →Sorin Group USA, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Mitroflow Aortic Heart Valve
Replacement of the native aortic valve or a previously implanted prosthetic aortic valve
Also known as: Mitroflow
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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Aortic Valve Regurgitation
Measure the level of aortic insufficiency (severity of backflow) in the Mitroflow valve.
Time frame: 12 months
| Milestone | Mitroflow Aortic Pericardial Valve |
|---|---|
| Started | 756 |
| Study cohort | 699 |
| Completed | 546 |
| Not completed | 210 |
| Withdrew: Death | 110 |
| Withdrew: Explant | 8 |
| Withdrew: Lost to follow-up | 5 |
| Withdrew: Withdrawal by subject | 30 |
| Withdrew: Protocol violation | 7 |
| Withdrew: Physician decision | 47 |
| Withdrew: Lack of efficacy | 3 |
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.
| Percent occurrence per patient-year | Mitroflow Aortic Pericardial Valve |
|---|---|
| All mortality | 7.1 (5.8 to 8.6) |
| Valve-related mortality | 1.27 (0.78 to 1.96) |
| Structural valve deterioration | 0.21 (0.06 to 0.56) |
| Major anticoagulant-related bleeding | 0.56 (0.27 to 1.06) |
| Thromboembolism | 1.34 (0.83 to 2.05) |
| Major thromboembolic event | 0.49 (0.22 to 0.97) |
| Valve thrombosis | 0 (0 to 0.17) |
| Endocarditis | 1.41 (0.89 to 2.13) |
| Non-structural valve dysfunction | 0.75 (0.40 to 1.29) |
| Perivalvular leak | 0.63 (0.31 to 1.16) |
| Hemolysis | 0 (0 to 0.17) |
| Valve reoperation | 0.85 (0.46 to 1.43) |
| Valve explant | 0.77 (0.41 to 1.34) |
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.
| mmHg | Mitroflow Aortic Pericardial Valve |
|---|---|
| Valve Size 19 | 13.4 ± 5 |
| Valve Size 21 | 11.4 ± 4.4 |
| Valve Size 23 | 10.5 ± 4.2 |
| Valve Size 25 | 8.6 ± 3.3 |
| Valve Size 27 | 7.3 ± 2.7 |
| Valve Size 29 | 7.3 ± 1.8 |
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.
| cm^2 | Mitroflow Aortic Pericardial Valve |
|---|---|
| Valve Size 19 | 1.1 ± 0.2 |
| Valve Size 21 | 1.2 ± 0.3 |
| Valve Size 23 | 1.4 ± 0.3 |
| Valve Size 25 | 1.6 ± 0.3 |
| Valve Size 27 | 1.8 ± 0.3 |
| Valve Size 29 | 2 ± 0.1 |
Measure the level of aortic insufficiency (severity of backflow) in the Mitroflow valve.
| Percent of participants | Mitroflow Aortic Pericardial Valve |
|---|---|
| None | 74.3 |
| Trace | 16.2 |
| Mild | 8.6 |
| Moderate | 0.9 |
| Severe | 0 |
Collected over All postop serious adverse events. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mitroflow Aortic Pericardial Valve | — | 351/699 (50.2%) | 430/699 (61.5%) |
| Event | Mitroflow Aortic Pericardial Valve |
|---|---|
| Heart failureCardiac disorders | 59/699 |
| Respiratory failure / disorderRespiratory, thoracic and mediastinal disorders | 35/699 |
| Respiratory infectionsRespiratory, thoracic and mediastinal disorders | 35/699 |
| Miscellaneous infectionsInfections and infestations | 34/699 |
| Miscellaneous GI disordersGastrointestinal disorders | 32/699 |
| Musculo-skeletal disordersMusculoskeletal and connective tissue disorders | 29/699 |
| Sepsis / bacteremiaInfections and infestations | 29/699 |
| Renal failure / insufficiencyRenal and urinary disorders | 28/699 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 26/699 |
| Cardiac arrhythmiasCardiac disorders | 24/699 |
| Event | Mitroflow Aortic Pericardial Valve |
|---|---|
| Atrial fibrillationCardiac disorders | 156/699 |
| Urinary tract infectionRenal and urinary disorders | 67/699 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 60/699 |
| Miscellaneous infectionsInfections and infestations | 53/699 |
| Respiratory infectionsRespiratory, thoracic and mediastinal disorders | 45/699 |
| Renal failure / insufficiencyRenal and urinary disorders | 40/699 |
| ArrhythmiasCardiac disorders | 36/699 |
| Heart failureCardiac disorders | 35/699 |
| Age, Categorical(Participants) | Mitroflow Aortic Pericardial Valve |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 96 |
| >=65 years | 603 |
| Age Continuous(years) | Mitroflow Aortic Pericardial Valve |
|---|---|
| Mean | 74.3 ± 8.4 |
| Sex: Female, Male(Participants) | Mitroflow Aortic Pericardial Valve |
|---|---|
| Female | 302 |
| Male | 397 |
| Region of Enrollment(participants) | Mitroflow Aortic Pericardial Valve |
|---|---|
| United States | 556 |
| Canada | 143 |
This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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Sorin Group USA, Inc.