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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Medtronic Cardiovascular
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular
ClinicalTrials.gov Identifier:
NCT00657826
First received: April 4, 2008
Last updated: December 16, 2013
Last verified: December 2013
  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.


Condition Intervention
Heart Valve Diseases
Device: ATS 3f(r) Aortic Bioprosthesis, Model 1000

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Assessment of hemodynamic performance shall include analysis of Doppler echocardiographic studies at the early and late postoperative evaluations.


Estimated Enrollment: 8
Study Start Date: October 2001
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ATS 3f(r) Aortic Bioprosthesis, Model 1000 Device: ATS 3f(r) Aortic Bioprosthesis, Model 1000
Isolated aortic valve replacement

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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 ClinicalTrials.gov identifier: NCT00657826

Contacts
Contact: Ryan Palmer 763-514-9732 ryan.j.palmer@medtronic.com

Locations
United States, Pennsylvania
Lankenau Institute for Medical Research Active, not recruiting
Wynnewood, Pennsylvania, United States, 19096
Canada, Quebec
McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Carole Albert, R.N.    514-934-1934 ext 35277    carole.albert@muhc.mcgill.ca   
Principal Investigator: Benoit de Varennes, M.D.         
Sponsors and Collaborators
Medtronic Cardiovascular
Investigators
Study Director: Ryan Palmer Medtronic
  More Information

Additional Information:
No publications provided

Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT00657826     History of Changes
Other Study ID Numbers: 2001 Rev. E
Study First Received: April 4, 2008
Last Updated: December 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Cardiovascular:
Diseased Heart Valve, Replacement

Additional relevant MeSH terms:
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 31, 2014