NCT00657826

ATS 3f(r) Aortic Bioprosthesis Model 1000, 19mm

ATS 3f(r) Aortic Bioprosthesis Model 1000

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Medtronic Cardiovascular · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The initial clinical investigation titled "ATS 3f(r) Aortic Bioprosthesis Model 1000 Study," was a prospective, non-randomized, multi-center study designed to evaluate the the safety and effectiveness obtained from 800 patient years using a common clinical protocol. Twenty-three (23) sites internationally and in the United States combined enrolled 405 patients. The objective of the study was to evaluate the safety and effectiveness of the ATS 3f(r) Aortic Bioprosthesis Model 1000 equine pericardial prosthesis in a a patient population undergoing isolated aortic valve replacement of his / her native aortic valve, or replacement of a failed prosthesis with or without concomitant procedures. Addendum: After receiving PMA approval in October of 2008 of the 21mm-29mm sizes, this IDE was expanded to comply with the conditions set forth in the approval notice. Study Protocol S2001 Rev. E is a continuation of the original protocol, but is only enrolling subjects who require a 19mm ATS 3f(r) Aortic Bioprosthesis, Model 1000 and is described as "A multi-center, non-randomized trial, designed to obtain 800 patient years. Each enrolled patient will be followed for a minimum one year and annually thereafter until size 19mm product approval or study cessation. Preoperative, discharge or 30 days (which ever comes last), 3-6 month, and annual follow-up data are required.

Detailed description

The patients for whom ATS Medical, Inc., ATS 3f(r) Aortic Bioprosthesis Model 1000 is intended are those patients whose prognosis without surgery for replacement of the diseased natural valve or previous implanted prosthetic valve is unacceptably poor in terms of survival, quality of life, or both, in the opinion of the attending physicians. For this special subset of patients, there are a number of widely accepted prosthetic heart valves in use.

Conditions

• Heart Valve Diseases

Interventions

Type	Name	Description
DEVICE	ATS 3f® Aortic Bioprosthesis, Model 1000, 19mm	Isolated aortic valve replacement with a size 19mm valve

Timeline

• Start date: 2001-10-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2008-04-14
• Last updated: 2016-06-22

Locations

2 sites across 2 countries: United States, Canada