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

This study has been terminated.
(Business decision to end study due to limited enrollment and study population)
Information provided by (Responsible Party):
Medtronic Cardiovascular Identifier:
First received: April 4, 2008
Last updated: June 20, 2016
Last verified: June 2016

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.

Condition Intervention
Heart Valve Diseases Device: ATS 3f® Aortic Bioprosthesis, Model 1000, 19mm

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ATS 3f(r) Aortic Bioprosthesis Model 1000

Resource links provided by NLM:

Further study details as provided by Medtronic Cardiovascular:

Primary Outcome Measures:
  • NYHA Functional Classification [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    Assessment of hemodynamic performance shall include analysis of Doppler echocardiographic studies at the early and late postoperative evaluations.

Enrollment: 22
Study Start Date: October 2001
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 19mm arotic valve implant
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
Isolated aortic valve replacement with a size 19mm valve

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.

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00657826

United States, Pennsylvania
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, United States, 19096
Canada, Quebec
McGill University Health Centre
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
Medtronic Cardiovascular
Study Director: Ryan Palmer Medtronic
  More Information

Additional Information:
Responsible Party: Medtronic Cardiovascular Identifier: NCT00657826     History of Changes
Other Study ID Numbers: 2001 Rev. E
Study First Received: April 4, 2008
Last Updated: June 20, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Medtronic Cardiovascular:
Diseased Heart Valve, Replacement

Additional relevant MeSH terms:
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases processed this record on September 21, 2017