Status:
TERMINATED
ATS 3f(r) Aortic Bioprosthesis Model 1000, 19mm
Lead Sponsor:
Medtronic Cardiovascular
Conditions:
Heart Valve Diseases
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The initial clinical investigation titled "ATS 3f(r) Aortic Bioprosthesis Model 1000 Study," was a prospective, non-randomized, multi-center study designed to evaluate the the safety and effectiveness...
Detailed Description
The patients for whom ATS Medical, Inc., ATS 3f(r) Aortic Bioprosthesis Model 1000 is intended are those patients whose prognosis without surgery for replacement of the diseased natural valve or previ...
Eligibility Criteria
Inclusion
- This patient requires isolated aortic valve replacement with or without concomitant procedures such as coronary artery bypass or another valve reconstruction. (The three remaining valves must be of native tissue).
- This patient is sufficiently ill to warrant replacement of his/her diseased natural or prosthetic valve, based on standard cardiovascular diagnostic workups.
- This patient is in satisfactory condition, based on the physical exam and investigator's experience, to be an average or better operative risk, (i.e., likely to survive one year postoperatively).
- This patient is geographically stable and willing to return to the implant center for follow-up visits.
- This patient has been adequately informed and consents to his/her participation in the clinical study, and of what will be required of him/her, in order to comply with the protocol.
Exclusion
- This patient is twenty (20) or less than twenty years of age.
- This patient has a non-cardiac major or progressive disease, which in the investigator's experience produces an unacceptable increased risk to the patient, or results in a life expectancy of less than 12 months.
- This patient is an intravenous drug and/or alcohol abuser.
- This female patient is pregnant (urine HCG test result positive), or lactating.
- This patient presents with active endocarditis.
- This patient presents with congenital bicuspid aortic anatomy.
- This patient has a previously implanted prosthetic valve that is not being replaced by a study valve.
- This patient requires mitral, tricuspid or pulmonic valve replacement.
- This patient is participating in concomitant research studies of investigational products.
- This patient will not agree to return to the implant center for the required number of follow-up visits or is geographically unavailable for follow-up.
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00657826
Start Date
October 1 2001
End Date
July 1 2015
Last Update
June 22 2016
Active Locations (2)
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1
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, United States, 19096
2
McGill University Health Centre
Montreal, Quebec, Canada, H3A 1A1