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

Heart Valve Diseases Clinical Trial

— PAS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01116037
• Other study ID #: S2008 Rev. D
• Status: Terminated
• Phase: N/A
• First received: April 8, 2010
• Last updated: December 15, 2015
• Start date: September 2009
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 70 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Valve Diseases

Intervention

Device:
• ATS 3f Aortic Bioprosthesis
Equine Pericardial Bioprosthesis for replacement of diseased valve

Locations

Country	Name	City	State
Canada	McGill University Health Center	Montreal	Quebec
United States	Baylor University	Dallas	Texas
United States	Columbia University	New York	New York
United States	Cardiac Surgery Clinical Research Center, Inc.	Oak Lawn	Illinois
United States	Univ of Pennsylvania Medical Center	Philadelphia	Pennsylvania
United States	Main Line Health Heart Center	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiovascular

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary efficacy goal is to assess the regurgitation rates	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	Yes
Secondary	Hemodynamic functional data	Hemodynamic functional data	Six Years	No
Secondary	Safety Analysis will be based on the occurence of cardiovascular complications.	Safety Analysis will be based on one the occurence of cardiovascular complications. Events will be classified as device-related and non-device related.	Six Years	Yes

External Links

•   Medtronic Corporate Website