Clinical trial NCT01116037: ATS 3f(r) Aortic Bioprosthesis Model 1000 Post Approval Study
Official title: ATS 3f(r) Aortic Bioprosthesis Model 1000 Post Approval Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Valve Diseases
Keywords: Diseased Heart Valve, Replacement, Aortic, Stentless
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2010-05-04
Enrollment: 26
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Six Years
Secondary outcomes:
measure: Safety Analysis Will be Based on the Occurence of Cardiovascular Complications.
timeFrame: Six Years
Other outcomes:
Locations:
city: Oak Lawn
country: United States
facility: Cardiac Surgery Clinical Research Center, Inc.
state: Illinois
city: New York
country: United States
facility: Columbia University
state: New York
city: Philadelphia
country: United States
facility: Univ of Pennsylvania Medical Center
state: Pennsylvania
city: Wynnewood
country: United States
facility: Main Line Health Heart Center
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor University
state: Texas
city: Montreal
country: Canada
facility: McGill University Health Center
state: Quebec
Study officials:
affiliation: Medtronic
name: Ryan Palmer
role: STUDY_DIRECTOR
References: