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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular
ClinicalTrials.gov Identifier:
NCT01116024
First received: April 8, 2010
Last updated: October 12, 2016
Last verified: October 2016
  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: 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:
  • Thromboembolism/Thrombosis [ Time Frame: Five Years ] [ Designated as safety issue: Yes ]

    Valve related thromboembolism and valvular thrombosis.

    Thrombosis was defined as any thrombus attached to or near the study valve that interfered with valve function in the absence of infection. The results are reported as linearized rate (percentage of participants per patient-year)


  • Hemorrhage/Bleeding-Anticoagulant/Antiaggregant (All and Major) [ Time Frame: Five Years ] [ Designated as safety issue: Yes ]

    Any episode of internal or external bleeding in subjects receiving anticoagulant and/or antiaggregant therapy.

    Hemorrhage/Bleeding (No Anticoagulant/Antiaggregant):

    Any episode of internal or external bleeding in subjects not receiving anticoagulant and/or antiaggregant therapy.

    The results are reported as linearized rate (percentage of participants per patient-year).


  • Paravalvular Leaks (All and Major) [ Time Frame: Five Years ] [ Designated as safety issue: Yes ]

    Paravalvular leak was defined as any evidence of leakage of blood around the prosthesis (between the sewing ring and native annulus). Major Paravalvular leak was defined as any evidence of leakage of blood around the prosthesis, i.e. between the sewing ring and native annulus that requires surgical intervention.

    The results are reported as linearized rate (percentage of participants per patient-year).


  • Endocarditis [ Time Frame: Five Years ] [ Designated as safety issue: Yes ]

    Endocarditis was defined in the protocol as any infection involving the study valve. Any structural/non-structural valvular dysfunction, thrombosis, or embolic event associated with study valve endocarditis was captured as endocarditis only.

    The results are reported as linearized rate (percentage of participants per patient-year).


  • Hemolysis [ Time Frame: Five Years ] [ Designated as safety issue: Yes ]
    Blood data analysis was performed in order to identify whether particular complications and serious adverse events such as hemolysis occurred. Hemolysis in subjects with tissue valves - as evidenced by increased serum lactate dehydrogenase concentrations, decreased serum haptoglobin concentration, erythrocytopenia and reticulocytosis - is usually associated with paravalvular leakage or infection.

  • Structural Valve Deterioration [ Time Frame: Five Years ] [ Designated as safety issue: Yes ]

    Structural deterioration was defined as any change in the study valve function which resulted from an intrinsic abnormality that caused stenosis or regurgitation.

    There were no cases of structural deterioration reported for the study.

    The results are reported as linearized rate (percentage of participants per patient-year).


  • Non-Structural Dysfunction [ Time Frame: Five Years ] [ Designated as safety issue: Yes ]

    Any abnormality resulting in stenosis or regurgitation at the operated valve that is not intrinsic to the valve itself. Non-structural dysfunction refers to non-structural problems that result in dysfunction of an operated valve exclusive of thrombosis and infection diagnosed by reoperation, autopsy, or clinical investigation.

    The results are reported as linearized rate (percentage of participants per patient-year).


  • Re-operation, Explant, Repair [ Time Frame: Five Years ] [ Designated as safety issue: Yes ]

    Reoperation was defined in the protocol as any operation to repair, alter, or replace the study valve. Included is reoperation for repair of paravalvular leak and explant.

    The results are reported as linearized rate (percentage of participants per patient-year).


  • Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance [ Time Frame: Five Years ] [ Designated as safety issue: No ]

    New York Heart Association (NYHA) classification to asses improvement of the cardiac status, Hemodynamic Performance analysis based on Doppler echocardiographic studies.

    Class I: Patients with cardiac disease but without limitations of ordinary activity.

    Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain.

    Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity results in fatigue, palpitations or anginal pain.

    Class IV: Patients with cardiac disease resulting in inability to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency or anginal syndrome may be present even at rest. If any physical activity is undertaken discomfort is increased.


  • Hemodynamic [ Time Frame: Five Years ] [ Designated as safety issue: No ]
    Mean and peak pressure gradients from discharge through 5 years follow up. The gradient represents the difference in blood pressure across the valve.

  • Hemodynamics - Effective Orifice Area [ Time Frame: Five Years ] [ Designated as safety issue: No ]

    Effective orifice area (EOA) data.

    The effective orifice area is a measure of how much the heart valve prosthesis impedes blood flow through the aortic valve.


  • Hemodynamics - Effective Orifice Area Index [ Time Frame: Five Years ] [ Designated as safety issue: No ]
    The effective orifice area index is a measure of how much the heart valve prosthesis impedes blood flow through the aortic valve.


Enrollment: 173
Study Start Date: May 2006
Study Completion Date: August 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3f Enable Aortic Bioprosthesis Model 6000
Single arm study
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   (Adult, Senior)
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:
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
Results First Received: May 26, 2016
Last Updated: October 12, 2016
Health Authority: Austria: Federal Ministry for Health Family and Youth
Germany: Regierungspraesidium Kassel
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
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on December 09, 2016