- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01116037
ATS 3f(r) Aortic Bioprosthesis Model 1000 Post Approval Study (PAS)
April 24, 2017 updated by: Medtronic Cardiovascular
The purpose of this clinical study is to determine if there is an increased incidence and rate of aortic regurgitation in younger (</= 70 years of age) patients implanted with the Model 1000 and undergoing isolated aortic valve replacement of his/her native aortic valve, or replacement of a failed prosthesis.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
A multi-center non-randomized trial designed to obtain 606 patient years.
Each enrolled patient will be followed for a minimum of six (6) years.
Preoperative, discharge or 30 days (whichever comes last), 3-6 month, and annual follow-up data are required.
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3A 1A1
- McGill University Health Center
-
-
-
-
Illinois
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Oak Lawn, Illinois, United States, 60453
- Cardiac Surgery Clinical Research Center, Inc.
-
-
New York
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New York, New York, United States, 10032
- Columbia University
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Univ of Pennsylvania Medical Center
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Wynnewood, Pennsylvania, United States, 19096
- Main Line Health Heart Center
-
-
Texas
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Dallas, Texas, United States, 75226
- Baylor University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 70 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient is </= 70 years of age and 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).
- Patient is sufficiently ill to warrant replacement of his/her diseased natural or prosthetic valve (excluding the ATS 3f Aortic Bioprosthesis, Model 1000 bioprosthesis), based on standard cardiovascular diagnostic workups.
- 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 three years postoperatively).
- Patient is geographically stable and willing to return to the implant center for follow-up visits.
- 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:
- Patient is older than seventy (70) years of age.
- 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 3 years.
- Patient is an intravenous drug and/or alcohol abuser.
- Female patient is pregnant (urine HCG test result positive), or lactating.
- Patient presents with active endocarditis.
- Patient presents with congenital bicuspid aortic anatomy.
- This patient presents with abnormal aortic root geometry.
- Patient has chronic renal failure or is on renal dialysis.
- Patient has a previously implanted prosthetic valve that is not being replaced by a study valve.
- Patient requires mitral, tricuspid or pulmonic valve replacement.
- Patient presents with dilatation of the ascending aorta, Marfan Syndrome, Ehlers-Danlos syndrome, cystic medial degeneration, or other condition causing the ascending aorta to be irregular in geometry or physiology as seen via preoperative imaging.
- Patient is participating in concomitant research studies of investigational products.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: ATS 3f Aortic Bioprosthesis
ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis)
|
Equine Pericardial Bioprosthesis for replacement of diseased valve
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Efficacy Goal is to Assess the Freedom From Clinically Significant (Moderate or Greater) Aortic Regurgitation for the Patients Implanted With 3f Aortic Bioprothesis, Model 1000
Time Frame: Six Years
|
Freedom from clinically significant (moderate or greater) aortic regurgitation will be determined through echocardiography and compared against the freedom from regurgitation event rates from the previous IDE study, G010284 used for PMA approval.
|
Six Years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety Analysis Will be Based on the Occurence of Cardiovascular Complications.
Time Frame: Six Years
|
Safety Analysis will be based on the the number of participants with cardiovascular complications.
|
Six Years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (ACTUAL)
November 1, 2015
Study Completion (ACTUAL)
November 1, 2015
Study Registration Dates
First Submitted
April 8, 2010
First Submitted That Met QC Criteria
May 3, 2010
First Posted (ESTIMATE)
May 4, 2010
Study Record Updates
Last Update Posted (ACTUAL)
May 25, 2017
Last Update Submitted That Met QC Criteria
April 24, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S2008 Rev. D
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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