N/A
N=756
Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve
Heart Valve Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00630916 ↗Enrolled (actual)
756
Serious AEs
50.2%
Results posted
Sep 2011
Primary outcome: Primary: Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair — 7.1; 1.27; 0.21; 0.56 Percent occurrence per patient-year
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mitroflow Aortic Heart Valve (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sorin Group USA, Inc.
- Primary completion
- Dec 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair |
7.1; 1.27; 0.21; 0.56; 1.34; 0.49 | — |
| PRIMARY Mean Gradient |
13.4; 11.4; 10.5; 8.6; 7.3; 7.3 | — |
| PRIMARY Effective Orifice Area |
1.1; 1.2; 1.4; 1.6; 1.8; 2 | — |
| SECONDARY Aortic Valve Regurgitation |
74.3; 16.2; 8.6; 0.9; 0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00630916). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.