Aortic Valve Disease, Endocarditis, Mitral Valve Disease
Conditions
Keywords
artificial heart valve, mitral heart valve, aortic heart valve, endocarditis, Aortic valve disease requiring replacement, Mitral valve disease requiring replacement
Brief summary
The purpose of this study is to investigate whether the Silzone coated sewing cuff reduces the incidence of prosthetic valve endocarditis (PVE).
Detailed description
The purpose of this study is to investigate whether the Silzone coated sewing cuff reduces the incidence of prosthetic valve endocarditis. The null and alternative hypotheses of this study are: * Ho: Patients receiving SJM Masters Series valves with Silzone coating will have an equal incidence of PVE when compared to those receiving the conventional cuff. * Ha: Patients receiving SJM Masters Series valves with Silzone coating will have a reduced incidence of PVE when compared to those receiving the conventional cuff.
Interventions
DEVICEArtificial Mechanical Heart Valve
Both arms used market released mechanical heart valves in accordance with approved labeling
Sponsors
University of Pittsburgh
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* The patient requires an isolated mitral, isolated aortic, or double (aortic and mitral) valve replacement * The patient is a candidate to receive an SJM (St. Jude Medical) Masters Series valve(s) with either the conventional cuff or the cuff with Silzone coating * The patient (or legal guardian) has signed a study-specific consent form agreeing to the randomization, data collection, and follow-up requirements
Exclusion criteria
* The patient has a medical condition which contraindicates implantation of the SJM Masters Series with Silzone coating * The patient already has a prosthetic valve other than the valve being replaced at this time * The patient requires a tricuspid valve replacement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Prosthetic Valve Endocarditis Comparing Conventional Valves to Silzone™ Coated Valves. | 1 year | Patient response to treatment with the Silzone™ treated valve will be evaluated based upon the incidence of early and late PVE (prosthetic valve endocarditis) in the treatment group vs. the control group. |
Countries
Canada, France, Germany, Italy, Netherlands, Spain, Switzerland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SJM Conventional SJM Standard Masters Series Mechanical Heart Valve with Conventional Cuff
Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling | 404 |
| SJM Silzone SJM Masters Series Mechanical Heart Valve with Silzone Coating
Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling | 403 |
| Total | 807 |
Baseline characteristics
| Characteristic | SJM Conventional | SJM Silzone | Total |
|---|---|---|---|
| Age, Customized <=18 years | 0 participants | 0 participants | 0 participants |
| Age, Customized >=65 years | 159 participants | 185 participants | 344 participants |
| Age, Customized Between 18 and 65 years | 244 participants | 218 participants | 462 participants |
| Sex: Female, Male Female | 168 Participants | 165 Participants | 333 Participants |
| Sex: Female, Male Male | 236 Participants | 238 Participants | 474 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 124 / 404 | 118 / 403 |
| serious Total, serious adverse events | 194 / 404 | 261 / 403 |
Outcome results
Primary
Incidence of Prosthetic Valve Endocarditis Comparing Conventional Valves to Silzone™ Coated Valves.
Patient response to treatment with the Silzone™ treated valve will be evaluated based upon the incidence of early and late PVE (prosthetic valve endocarditis) in the treatment group vs. the control group.
Time frame: 1 year
Population: subjects randomized into the study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SJM Conventional | Incidence of Prosthetic Valve Endocarditis Comparing Conventional Valves to Silzone™ Coated Valves. | 10 participants |
| SJM Silzone | Incidence of Prosthetic Valve Endocarditis Comparing Conventional Valves to Silzone™ Coated Valves. | 9 participants |