Aortic Valve Disease
Conditions
Keywords
aortic valve, heart valve, valve replacement, Valve disease
Brief summary
The purpose of this study is to compare the sizing and implant techniques between the CarboMedics Top Hat supra-annular valve and the St. Jude Medical Regent valve.
Interventions
DEVICETop Hat
Implant of CarboMedics Top Hat mechanical valve.
DEVICERegent
Implant of the St. Jude Medical Regent mechanical valve
Sponsors
Sorin Group USA, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are indicated for implant with a mechanical valve prosthesis in the aortic position according to the current practice for valve selection at the center.
Exclusion criteria
* Patients \< 18 years of age * Emergency surgery * Pre-existing valve prosthesis * Aortic root replacement * Active endocarditis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effective Orifice Area (EOA) | 6 month evaluation | Effective Orifice Area of the prosthetic valve measured via echocardiography to determine physiological area of blood flow through the valve. |
| Aortic Mean Gradient | 6 months | Mean gradient measured across the aortic prosthetic valve via echocardiography to determine mean pressure of blood flow across the valve. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Top Hat Valve CarboMedics Supra-annular Top Hat Valve | 2 |
| St.Jude Valve St. Jude Medical Regent Valve | 0 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study terminated prior to followup | 1 | 0 |
Baseline characteristics
| Characteristic | Top Hat Valve | Total |
|---|---|---|
| Age, Customized <18 years | 0 participants | 0 participants |
| Age, Customized >= 18 years | 2 participants | 2 participants |
| Region of Enrollment United States | 2 participants | 2 participants |
| Sex/Gender, Customized Female | NA participants | — |
| Sex/Gender, Customized Male | NA participants | — |
| Sex/Gender, Customized Unknown | 2 participants | 2 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 2 | 0 / 0 |
| serious Total, serious adverse events | 0 / 2 | 0 / 0 |
Outcome results
Primary
Aortic Mean Gradient
Mean gradient measured across the aortic prosthetic valve via echocardiography to determine mean pressure of blood flow across the valve.
Time frame: 6 months
Population: Analysis not performed due to study termination prior to analysis period.
Primary
Effective Orifice Area (EOA)
Effective Orifice Area of the prosthetic valve measured via echocardiography to determine physiological area of blood flow through the valve.
Time frame: 6 month evaluation
Population: Analysis not performed due to study termination prior to analysis period.