ATS 3f(r) Aortic Bioprosthesis Model 1000 Post Approval Study

Stopped early · Not applicable

Conditions studied: Heart Valve Diseases

In brief

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.

Key facts

Study ID

NCT01116037

Run by

Medtronic Cardiovascular

People needed

26

Starts

2009-09-01

Expected to finish

2015-11-01

Last updated by the study team

2017-05-25

Who can join

Age: any, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cardiac Surgery Clinical Research Center, Inc. — Oak Lawn, Illinois, United States
• Columbia University — New York, New York, United States
• Univ of Pennsylvania Medical Center — Philadelphia, Pennsylvania, United States
• Main Line Health Heart Center — Wynnewood, Pennsylvania, United States
• Baylor University — Dallas, Texas, United States
• McGill University Health Center — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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