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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01116037
Recruitment Status : Terminated (Business decision to end study due to limited enrollment and study population)
First Posted : May 4, 2010
Results First Posted : May 25, 2017
Last Update Posted : May 25, 2017
Information provided by (Responsible Party):
Medtronic Cardiovascular

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.

Condition or disease Intervention/treatment Phase
Heart Valve Diseases Device: ATS 3f Aortic Bioprosthesis Not Applicable

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  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ATS 3f(r) Aortic Bioprosthesis Model 1000 Post Approval Study
Study Start Date : September 2009
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
ATS 3f Aortic Bioprosthesis
ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis)
Device: ATS 3f Aortic Bioprosthesis
Equine Pericardial Bioprosthesis for replacement of diseased valve

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01116037

United States, Illinois
Cardiac Surgery Clinical Research Center, Inc.
Oak Lawn, Illinois, United States, 60453
United States, New York
Columbia University
New York, New York, United States, 10032
United States, Pennsylvania
Univ of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
Main Line Health Heart Center
Wynnewood, Pennsylvania, United States, 19096
United States, Texas
Baylor University
Dallas, Texas, United States, 75226
Canada, Quebec
McGill University Health Center
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
Medtronic Cardiovascular
Study Director: Ryan Palmer Medtronic

Additional Information:
Responsible Party: Medtronic Cardiovascular Identifier: NCT01116037     History of Changes
Other Study ID Numbers: S2008 Rev. D
First Posted: May 4, 2010    Key Record Dates
Results First Posted: May 25, 2017
Last Update Posted: May 25, 2017
Last Verified: April 2017

Keywords provided by Medtronic Cardiovascular:
Diseased Heart Valve, Replacement, Aortic, Stentless

Additional relevant MeSH terms:
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases