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

April 8, 2010
December 16, 2013
September 2009
November 2020   (final data collection date for primary outcome measure)
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.
Primary efficacy goal is to assess the regurgitation rates [ Time Frame: One Year ] [ Designated as safety issue: No ]
Freedom from clinically significant (moderate or greater) aortic regurgitation will be determined through echocardiography and compared against the freedom from regurgitation event rates from teh previous IDE study, G010284 used for PMA approval.
Complete list of historical versions of study NCT01116037 on ClinicalTrials.gov Archive Site
  • 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.
  • Hemodynamic functional data and NYHA functional class are the secondary effectiveness analysis [ Time Frame: One Year ] [ Designated as safety issue: No ]
    Hemodynamic functional data and NYHA functional class are the secondary effectiveness analysis
  • Safety Analysis will be based on the occurence of cardiovascular complications. [ Time Frame: One Year ] [ 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.
Not Provided
Not Provided
 
ATS 3f(r) Aortic Bioprosthesis Model 1000 Post Approval Study
ATS 3f(r) Aortic Bioprosthesis Model 1000 Post Approval Study

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Valve Diseases
Device: ATS 3f Aortic Bioprosthesis
Equine Pericardial Bioprosthesis for replacement of diseased valve
ATS 3f Aortic Bioprosthesis
ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis)
Intervention: Device: ATS 3f Aortic Bioprosthesis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
127
February 2021
November 2020   (final data collection date for primary outcome measure)

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.
Both
up to 70 Years
No
Contact: Ryan Palmer ryan.j.palmer@medtronic.com
United States,   Canada
 
NCT01116037
S2008 Rev. D
No
Medtronic Cardiovascular
Medtronic Cardiovascular
Not Provided
Study Director: Ryan Palmer Medtronic
Medtronic Cardiovascular
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP