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

• ClinicalTrials.gov Identifier: NCT01116037
• Recruitment Status: Terminated
• First Posted: May 4, 2010
• Results First Posted: May 25, 2017
• Last Update Posted: May 25, 2017
• Sponsor: Medtronic Cardiovascular
• Information provided by (Responsible Party): Medtronic Cardiovascular

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 26 participants
• Allocation: N/A
• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• Ages Eligible for Study: up to 70 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

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

Investigators

• Study Director: Ryan Palmer; Medtronic

More Information

Additional Information:

Medtronic Corporate Website 

• Responsible Party: Medtronic Cardiovascular
• ClinicalTrials.gov Identifier: NCT01116037
• Other Study ID Numbers: S2008 Rev. D
• First Posted: May 4, 2010
• 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