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ATS 3f Enable(tm) Aortic Bioprosthesis, Model 6000

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Medtronic Cardiovascular.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular
ClinicalTrials.gov Identifier:
NCT01116024
First received: April 8, 2010
Last updated: February 14, 2012
Last verified: February 2012
  Purpose

This is a prospective, non-randomized, multi-center study designed to evaluate safety and effectiveness of the ATS 3f Enable Aortic Bioprosthesis in a patient population undergoing isolated aortic valve replacement with or without concomitant procedures. The Enable Aortic Valve is an equine pericardial stented bioprosthesis.


Condition Intervention
Heart Valve Diseases
Device: ATS 3f Enable Aortic Bioprosthesis Model 6000

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 Enable(tm) Aortic Bioprosthesis, Model 6000

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiovascular:

Primary Outcome Measures:
  • Migration [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
    Migration is defined as complete or partial displacement (tilting) of the device from its original locus resulting in coronary ostia blockage, perivalvular leak, or incompetence.

  • Thromboembolism/Thrombosis [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
    Valve related thromboembolism and valvular thrombosis.

  • Hemorrhage (all and major) [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
    All bleeding events regardless of whether or not the event is related to anticoagulation therapy and will be categorized as minor and major events.

  • Perivalvular Leaks (all and major) [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
    All perivalvular leak events will be reported.

  • Endocarditis [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
    Study valve endocarditis.

  • Hemolysis [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
    Hematology/Chemistry data will be analyzed to determine if significant subclinical or unreported hemolysis is occuring.

  • Structural Valve Deterioration [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
    Structural valve deterioration data will be collected.

  • Non-Structural Dysfunction [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
    Perivalvular Leak, Hemolysis, Entrapment by pannus, tissue or suture, Inappropriate sizing or positioning, and Distortion.

  • Re-operation, Explant, Death (all Deaths and valve related) [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
    Re-operations, Explant, and Death (all Deaths and valve related)


Secondary Outcome Measures:
  • Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance [ Time Frame: One Year ] [ Designated as safety issue: No ]
    NYHA classification to asses improvement of the cardiac status, Hemodynamic Performance analysis based on Doppler echocardiographic studies.


Enrollment: 173
Study Start Date: May 2006
Estimated Study Completion Date: August 2014
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ATS 3f Enable Aortic Bioprosthesis Model 6000 Device: ATS 3f Enable Aortic Bioprosthesis Model 6000
Replacement Aortic Heart Valve

Detailed Description:

The ATS 3f Enable Aortic Bioprosthesis is intended for those patients whose prognosis without surgical replacement of the diseased natural valve is unacceptably poor in terms of survival and/or quality of life in the opinion of the attending physicians. For these 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:

  • The patient requires isolated aortic valve replacement with or without concomitant procedures such as coronary artery bypass or another valve repair. (The three remaining valves must be of native tissue).
  • The patient is geographically stable and willing to return to the implant site for follow-up visits.
  • The patient has been adequately informed of risks and requirements and consent to his/her participation in the clinical study.
  • If this patient is female and of childbearing potential, patient has a negative pregnancy test within seven (7) days prior to the study procedure.

Exclusion Criteria:

  • The patient requires replacement of two or more valves.
  • The patient is < 20 years of age.
  • The 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 24 months.
  • The patient is an intravenous drug and/or alcohol abuser.
  • The patient presents with active endocarditis or other systemic infection.
  • The patient has had previous valve replacement surgery, including previous implant and then explant of the ATS 3f Enable Aortic Bioprosthesis (Model 6000) or placement of a rigid annuloplasty ring in the mitral position.
  • The patient is participating in concomitant research studies of investigational products.
  • The patient presents with dilatation of the ascending aorta, Marfan Syndrome, Ehlers-Danlos syndrome, cystic medial degeneration, or other condition causing the ascending aorta to be irregular in geometry or physiology as seen via preoperative imaging.
  • The patient has chronic renal failure.
  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: NCT01116024

Locations
Austria
Medical University of Vienna
Vienna, Austria
Germany
Johann Wolfgang Goethe University
Frankfurt, Germany
University Medical Center Freiburg
Freiburg, Germany
University Medical Center Kiel
Kiel, Germany
UKSH, Campus Lubeck
Lubeck, Germany
Poland
Medical University of Gdansk
Gdansk, Poland
Jagiellonian University
Krakow, Poland
Switzerland
Cardiac Surgery University Hospital Basel
Basel, Switzerland
Inselspital Bern
Bern, Switzerland
United Kingdom
John Radcliffe Hospital
Oxford, United Kingdom
Sponsors and Collaborators
Medtronic Cardiovascular
Investigators
Study Director: Eric Vang Medtronic
  More Information

Additional Information:
No publications provided

Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT01116024     History of Changes
Other Study ID Numbers: S2005 Rev. 17-MAY-2007
Study First Received: April 8, 2010
Last Updated: February 14, 2012
Health Authority: Austria: Federal Ministry for Health Family and Youth
Germany: Paul-Ehrlich-Institut
Poland: Ministry of Health
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Medtronic Cardiovascular:
Diseased Heart Valve, Replacement, Aortic

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

ClinicalTrials.gov processed this record on November 24, 2014