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

NCT01116037 | Terminated Results

• 1 other identifier: S2008 Rev. D
• Study Type: interventional
• Target: 26
• Locations: 2 countries
• Sites: 6

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.

Conditions

Heart Valve Diseases

Keywords

Diseased Heart Valve, Replacement, Aortic, Stentless

Outcome Measures

Primary Outcomes (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

  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.

  Six Years

Secondary Outcomes (1)

• Safety Analysis Will be Based on the Occurence of Cardiovascular Complications.

  Six Years

Study Arms (1)

ATS 3f Aortic Bioprosthesis

OTHER

ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis)

Device: ATS 3f Aortic Bioprosthesis

Interventions

ATS 3f Aortic Bioprosthesis DEVICE

Equine Pericardial Bioprosthesis for replacement of diseased valve

ATS 3f Aortic Bioprosthesis

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (6)

Cardiac Surgery Clinical Research Center, Inc.

Oak Lawn, Illinois, 60453, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Univ of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Main Line Health Heart Center

Wynnewood, Pennsylvania, 19096, United States

Location

Baylor University

Dallas, Texas, 75226, United States

Location

McGill University Health Center

Montreal, Quebec, H3A 1A1, Canada

Location

Related Links

• Medtronic Corporate Website

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Ryan Palmer
• Organization: Medtronic

ryan.j.palmer@medtronic.com

+17635149732

Study Officials

• Ryan Palmer

  Medtronic

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2010
• First Posted: May 4, 2010
• Study Start: September 1, 2009
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: May 25, 2017
• Results First Posted: May 25, 2017

Record last verified: 2017-04

Locations

CA (1); US (5)