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

NCT00657826 | Terminated DMC

• 1 other identifier: 2001 Rev. E
• Study Type: interventional
• Target: 22
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Heart Valve Diseases

Keywords

Diseased Heart Valve, Replacement

Outcome Measures

Primary Outcomes (4)

• NYHA Functional Classification

  The NYHA classifications will be analyzed to demonstrate if implanting of the study valve leads to an improvement in this clinical parameter for the patient.

  3-6 months, 11-14 months, anuually for a minimum of 800 patient years to support a PMA application to the U.S. FDA

• Blood Data

  Blood data will be analyzed preoperatively and postoperatively to deomonstrate if implanting of the study valve results in acceptable parameters for SLDH, Haptoglobin, Hematocrit and Reticulocyte parameters. Platelet and white blood cell count will also be analyzed.

  3-6 months, 11-14 months, anuually for a minimum of 800 patient years to support a PMA application to the U.S. FDA

• Cardiovascular Complications

  All cardiovascular related complications should be conducted and evaluated according to the STS guidelines. In reporting complications, all cardiovascular related symptoms will be evaluated as to their relation to the valve.

  3-6 months, 11-14 months, anuually for a minimum of 800 patient years to support a PMA application to the U.S. FDA

• Hemodynamic Performance

  Assessment of hemodynamic performance shall include analysis of Doppler echocardiographic studies at the early and late postoperative evaluations.

  3-6 months, 11-14 months, anuually for a minimum of 800 patient years to support a PMA application to the U.S. FDA

Study Arms (1)

19mm arotic valve implant

EXPERIMENTAL

Single arm study for patients who require a smaller valve size of the ATS 3f® Aortic Bioprosthesis, Model 1000, 19mm.

Device: ATS 3f® Aortic Bioprosthesis, Model 1000, 19mm

Interventions

ATS 3f® Aortic Bioprosthesis, Model 1000, 19mm DEVICE

Isolated aortic valve replacement with a size 19mm valve

19mm arotic valve implant

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• This patient 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).
• This patient is sufficiently ill to warrant replacement of his/her diseased natural or prosthetic valve, based on standard cardiovascular diagnostic workups.
• This 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 one year postoperatively).
• This patient is geographically stable and willing to return to the implant center for follow-up visits.
• This 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:

• This patient is twenty (20) or less than twenty years of age.
• This 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 12 months.
• This patient is an intravenous drug and/or alcohol abuser.
• This female patient is pregnant (urine HCG test result positive), or lactating.
• This patient presents with active endocarditis.
• This patient presents with congenital bicuspid aortic anatomy.
• This patient has a previously implanted prosthetic valve that is not being replaced by a study valve.
• This patient requires mitral, tricuspid or pulmonic valve replacement.
• This patient is participating in concomitant research studies of investigational products.
• This 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 (2)

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, 19096, United States

Location

McGill University Health Centre

Montreal, Quebec, H3A 1A1, Canada

Location

Related Links

• Medtronic, Inc. Corporate website

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Ryan Palmer

  Medtronic

  STUDY DIRECTOR

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 4, 2008
• First Posted: April 14, 2008
• Study Start: October 1, 2001
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: June 22, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CA (1)