Study Stopped
Study stopped due to lack of elegible patient enrollment
CarboMedics Top Hat vs St. Jude Medical Regent Valve Comparing Sizing and Hemodynamics
A Randomized Study to Compare Sizing, Implant Techniques, & Hemodynamic Performance Between the CarboMedics Supra-annular Top Hat Valve and the St. Jude Medical Regent Valve in the Aortic Position.
1 other identifier
interventional
2
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2007
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 10, 2008
CompletedFirst Posted
Study publicly available on registry
February 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedResults Posted
Study results publicly available
November 3, 2011
CompletedNovember 16, 2011
September 1, 2011
5 months
January 10, 2008
June 7, 2011
November 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Effective Orifice Area (EOA)
Effective Orifice Area of the prosthetic valve measured via echocardiography to determine physiological area of blood flow through the valve.
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.
6 months
Study Arms (2)
1
ACTIVE COMPARATORCarboMedics Supra-annular Top Hat Valve
2
ACTIVE COMPARATORSt. Jude Medical Regent Valve
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients \< 18 years of age
- Emergency surgery
- Pre-existing valve prosthesis
- Aortic root replacement
- Active endocarditis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, 37660, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Early termination due to low enrollment resulted in only 2 patients. Insufficient data for analysis.
Results Point of Contact
- Title
- Barbara Mathews Director Clinical and Medical Affairs
- Organization
- Sorin Group USA, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2008
First Posted
February 20, 2008
Study Start
December 1, 2007
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
November 16, 2011
Results First Posted
November 3, 2011
Record last verified: 2011-09