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

Primary Purpose

Heart Valve Diseases

Status

Terminated

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Heart Valve Diseases focused on measuring Diseased Heart Valve, Replacement

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Lankenau Institute for Medical Research
McGill University Health Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

19mm arotic valve implant

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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.

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.

Hemodynamic Performance

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00657826

First Posted

April 4, 2008

Last Updated

June 20, 2016

Sponsor

Medtronic Cardiovascular

1. Study Identification

Unique Protocol Identification Number

NCT00657826

Brief Title

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

Official Title

ATS 3f(r) Aortic Bioprosthesis Model 1000

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Terminated

Why Stopped

Business decision to end study due to limited enrollment and study population

Study Start Date

October 2001 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic Cardiovascular

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Valve Diseases

Keywords

Diseased Heart Valve, Replacement

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

19mm arotic valve implant

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

Isolated aortic valve replacement with a size 19mm valve

Primary Outcome Measure Information:

Title

NYHA Functional Classification

Description

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.

Time Frame

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

Title

Blood Data

Description

Time Frame

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

Title

Cardiovascular Complications

Description

Time Frame

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

Title

Hemodynamic Performance

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ryan Palmer

Organizational Affiliation

Medtronic

Official's Role

Study Director

Facility Information:

Facility Name

Lankenau Institute for Medical Research

City

Wynnewood

State/Province

Pennsylvania

ZIP/Postal Code

19096

Country

United States

Facility Name

McGill University Health Centre

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 1A1

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

http://www.medtronic.com/

Description

Medtronic, Inc. Corporate website

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

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