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

This study is currently recruiting participants.
Verified August 2012 by Medtronic Cardiovascular
Sponsor:
Information provided by:
Medtronic Cardiovascular
ClinicalTrials.gov Identifier:
NCT01116037
First received: April 8, 2010
Last updated: August 27, 2012
Last verified: August 2012
  Purpose

The purpose of this clinical study is to determine if there is an increased incidence and rate of aortic regurgitation in younger (</= 60 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 Intervention
Heart Valve Diseases
Device: ATS 3f Aortic Bioprosthesis

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Post Approval Clinical Study for ATS 3f Aortic Bioprosthesis Model 1000 Study No. 2008, Rev. B

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiovascular:

Primary Outcome Measures:
  • Primary efficacy goal is to assess the regurgitation rates [ Time Frame: Six Years ] [ Designated as safety issue: Yes ]
    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:
  • Hemodynamic functional data [ Time Frame: Six Years ] [ Designated as safety issue: No ]
    Hemodynamic functional data

  • Safety Analysis will be based on the occurence of cardiovascular complications. [ Time Frame: Six Years ] [ Designated as safety issue: Yes ]
    Safety Analysis will be based on one the occurence of cardiovascular complications. Events will be classified as device-related and non-device related.


Estimated Enrollment: 127
Study Start Date: September 2009
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   up to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is </= 60 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 sixty (60) 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.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01116037

Contacts
Contact: Jessica Halverson, RN, BSN, PHN jessica.halverson@medtronic.com

Locations
United States, California
UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Msgana Tamrat     310-825-1407     mtamrat@mednet.ucla.edu    
Principal Investigator: Richard Shemin, MD            
Sub-Investigator: Jamil Aboulhosn, MD            
United States, Illinois
Cardiac Surgery Clinical Research Center, Inc. Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Mary Jane Borg     708-346-4040     mborg@cvtsurgeons.com    
Principal Investigator: Patroklos Pappas, MD            
Sub-Investigator: Antone Tatooles, MD            
United States, Missouri
University of Kansas Medical Center Recruiting
Kansas City, Missouri, United States, 66160
Contact: Susie Page     913-588-9720     spage3@mac.md    
Principal Investigator: George Zorn, MD            
Sub-Investigator: Gregory Muehlebach, MD            
Sub-Investigator: Kevin Mulhern, MD            
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Lyn Goldsmith     212-342-0261     lg2240@columbia.edu    
Principal Investigator: Allan Stewart, MD            
United States, Pennsylvania
Univ of Pennsylvania Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Lauren Solometo     215-662-8480     lauren.solometo@uphs.upenn.edu    
Principal Investigator: Clark Hargrove, MD            
Sub-Investigator: Wilson Szeto, MD            
Main Line Health Heart Center Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Susan Herring, RN     484-476-8514     herrings@mlhs.org    
Principal Investigator: Francis Ferdinand, MD            
Sub-Investigator: Scott Goldman, MD            
Sub-Investigator: Roberto Rodriguez, MD            
United States, Texas
Baylor University Recruiting
Dallas, Texas, United States, 75226
Contact: Ja'karsha Culton     214-820-2273     jakarsc@baylorhealth.edu    
Principal Investigator: Robert Hebeler, M.D.            
Sub-Investigator: Cara East, MD            
Sponsors and Collaborators
Medtronic Cardiovascular
Investigators
Study Director: Jessica Halverson, RN, BSN, PHN Medtronic
  More Information

Additional Information:
No publications provided

Responsible Party: Eszter Pais, Senior Clinical Research Specialist, Medtronic, Inc.
ClinicalTrials.gov Identifier: NCT01116037     History of Changes
Other Study ID Numbers: S2008 Rev. B
Study First Received: April 8, 2010
Last Updated: August 27, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 16, 2013