ATS 3f(r) Aortic Bioprosthesis Model 1000, 19mm
| Status: | Terminated |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2001 |
| End Date: | July 2015 |
ATS 3f(r) Aortic Bioprosthesis Model 1000
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 obtained from 800 patient years using a common clinical protocol.
Twenty-three (23) sites internationally and in the United States combined enrolled 405
patients. The objective of the study was to evaluate the safety and effectiveness of the ATS
3f(r) Aortic Bioprosthesis Model 1000 equine pericardial prosthesis in a a patient
population undergoing isolated aortic valve replacement of his / her native aortic valve, or
replacement of a failed prosthesis with or without concomitant procedures.
Addendum: After receiving PMA approval in October of 2008 of the 21mm-29mm sizes, this IDE
was expanded to comply with the conditions set forth in the approval notice. Study Protocol
S2001 Rev. E is a continuation of the original protocol, but is only enrolling subjects who
require a 19mm ATS 3f(r) Aortic Bioprosthesis, Model 1000 and is described as "A
multi-center, non-randomized trial, designed to obtain 800 patient years. Each enrolled
patient will be followed for a minimum one year and annually thereafter until size 19mm
product approval or study cessation. Preoperative, discharge or 30 days (which ever comes
last), 3-6 month, and annual follow-up data are required.
was a prospective, non-randomized, multi-center study designed to evaluate the the safety
and effectiveness obtained from 800 patient years using a common clinical protocol.
Twenty-three (23) sites internationally and in the United States combined enrolled 405
patients. The objective of the study was to evaluate the safety and effectiveness of the ATS
3f(r) Aortic Bioprosthesis Model 1000 equine pericardial prosthesis in a a patient
population undergoing isolated aortic valve replacement of his / her native aortic valve, or
replacement of a failed prosthesis with or without concomitant procedures.
Addendum: After receiving PMA approval in October of 2008 of the 21mm-29mm sizes, this IDE
was expanded to comply with the conditions set forth in the approval notice. Study Protocol
S2001 Rev. E is a continuation of the original protocol, but is only enrolling subjects who
require a 19mm ATS 3f(r) Aortic Bioprosthesis, Model 1000 and is described as "A
multi-center, non-randomized trial, designed to obtain 800 patient years. Each enrolled
patient will be followed for a minimum one year and annually thereafter until size 19mm
product approval or study cessation. Preoperative, discharge or 30 days (which ever comes
last), 3-6 month, and annual follow-up data are required.
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 previous implanted prosthetic valve is unacceptably poor in terms of
survival, quality of life, or both, in the opinion of the attending physicians. For this
special subset of patients, there are a number of widely accepted prosthetic heart valves in
use.
intended are those patients whose prognosis without surgery for replacement of the diseased
natural valve or previous implanted prosthetic valve is unacceptably poor in terms of
survival, quality of life, or both, in the opinion of the attending physicians. For this
special subset of patients, there are a number of widely accepted prosthetic heart valves in
use.
Inclusion Criteria:
- 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 Criteria:
- 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.
We found this trial at
2
sites
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