An interventional study of Top Hat and Regent in Aortic Valve Disease, sponsored by Sorin Group USA, Inc.. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-11-16.
Sponsored by Sorin Group USA, Inc. (part of LivaNova) · Not applicable and Interventional
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.
234 studies on the registry are indexed under Aortic Valve Disease; 75 are open to participants now.
This study's enrollment of 2 is below the median of 107 across 119 interventional studies indexed under Aortic Valve Disease.
Browse Aortic Valve Disease studies →Sorin Group USA, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
First submitted before Sorin Group USA, Inc. became part of LivaNova.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
CarboMedics Supra-annular Top Hat Valve
Device: Top Hat
St. Jude Medical Regent Valve
Device: Regent
Implant of CarboMedics Top Hat mechanical valve.
Implant of the St. Jude Medical Regent mechanical valve
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
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
| Milestone | Top Hat Valve | St.Jude Valve |
|---|---|---|
| Started | 2 | 0 |
| Completed | 1 | 0 |
| Not completed | 1 | 0 |
| Withdrew: Study terminated prior to followup | 1 | 0 |
Effective Orifice Area of the prosthetic valve measured via echocardiography to determine physiological area of blood flow through the valve.
No measurements were reported for this outcome.
Mean gradient measured across the aortic prosthetic valve via echocardiography to determine mean pressure of blood flow across the valve.
No measurements were reported for this outcome.
Collected over Duration of hospital stay after surgery, an average of 4 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Top Hat Valve | — | 0/2 (0%) | 0/2 (0%) |
| St.Jude Valve | — | — | — |
| Age, Customized(participants) | Top Hat Valve | St.Jude Valve | Total |
|---|---|---|---|
| <18 years | 0 | — | 0 |
| >= 18 years | 2 | — | 2 |
| Sex/Gender, Customized(participants) | Top Hat Valve | St.Jude Valve | Total |
|---|---|---|---|
| Unknown | 2 | — | 2 |
| Female | NA | — | — |
| Male | NA | — | — |
| Region of Enrollment(participants) | Top Hat Valve | St.Jude Valve | Total |
|---|---|---|---|
| United States | 2 | — | 2 |
This study is terminated, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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