Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Wynnewood, Pennsylvania 19096


Purpose:

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

2001 Rev. E


NCT ID:

NCT00657826


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

ATS 3f(r) Aortic Bioprosthesis Model 1000


Overall Status:

Terminated


Study Phase:

N/A


Genders:

Both


Minimum Age:

21 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Medtronic Cardiovascular


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

Business decision to end study due to limite


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety/Efficacy Study, In


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

22


Enrollment Type:

Actual


Overall Contact Information

Official Name:Ryan Palmer
Study Director
Medtronic

Study Dates

Start Date:October 2001
Completion Date:July 2015
Completion Type:Actual
Primary Completion Date:July 2015
Primary Completion Type:Actual
Verification Date:June 2016
Last Changed Date:June 20, 2016
First Received Date:April 4, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Hemodynamic Performance
Time Frame:3-6 months, 11-14 months, anuually for a minimum of 800 patient years to support a PMA application t
Safety Issues:False
Description:Assessment of hemodynamic performance shall include analysis of Doppler echocardiographic studies at the early and late postoperative evaluations.
Outcome Type:Primary Outcome
Measure:Cardiovascular Complications
Time Frame:3-6 months, 11-14 months, anuually for a minimum of 800 patient years to support a PMA application t
Safety Issues:True
Description: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.
Outcome Type:Primary Outcome
Measure:Blood Data
Time Frame:3-6 months, 11-14 months, anuually for a minimum of 800 patient years to support a PMA application t
Safety Issues:True
Description: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 b
Outcome Type:Primary Outcome
Measure:NYHA Functional Classification
Time Frame:3-6 months, 11-14 months, anuually for a minimum of 800 patient years to support a PMA application t
Safety Issues:False
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.

Study Interventions

Intervention Type:Device
Name:ATS 3f® Aortic Bioprosthesis, Model 1000, 19mm
Description:Isolated aortic valve replacement with a size 19mm valve
Arm Name:19mm arotic valve implant

Study Arms

Study Arm Type:Experimental
Arm Name:19mm arotic valve implant
Description:Single arm study for patients who require a smaller valve size of the ATS 3f® Aortic Bioprosthesis, Model 1000, 19mm.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Medtronic Cardiovascular

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.