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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Medtronic Cardiovascular
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular
ClinicalTrials.gov Identifier:
NCT01116037
First received: April 8, 2010
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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

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: February 2021
Estimated Primary Completion Date: November 2020 (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 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116037

Contacts
Contact: Ryan Palmer ryan.j.palmer@medtronic.com

Locations
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, 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: Laura Schuck    215-662-8480    laura.schuck@uphs.upenn.edu   
Principal Investigator: Clark Hargrove, MD         
Sub-Investigator: Wilson Szeto, MD         
Main Line Health Heart Center Active, not recruiting
Wynnewood, Pennsylvania, United States, 19096
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         
Canada, Quebec
McGill University Health Center Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Isabel Szczepkowski, RN    514-934-1934 ext 35277    isabel.szczepkowski@muhc.mcgill.ca   
Contact: Carole Albert, RN    514-934-1934 ext 35277    carole.albert@muhc.mcgill.ca   
Principal Investigator: Benoit de Varennes, MD         
Sponsors and Collaborators
Medtronic Cardiovascular
Investigators
Study Director: Ryan Palmer Medtronic
  More Information

Additional Information:
No publications provided

Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT01116037     History of Changes
Other Study ID Numbers: S2008 Rev. D
Study First Received: April 8, 2010
Last Updated: December 16, 2013
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
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 23, 2014