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

Primary Purpose

Heart Valve Diseases

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ATS 3f Enable Aortic Bioprosthesis Model 6000
Sponsored by
Medtronic Cardiovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Valve Diseases focused on measuring Diseased Heart Valve, Replacement, Aortic

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical University of Vienna
  • Johann Wolfgang Goethe University
  • University Medical Center Freiburg
  • University Medical Center Kiel
  • UKSH, Campus Lubeck
  • Medical University of Gdansk
  • Jagiellonian University
  • Cardiac Surgery University Hospital Basel
  • Inselspital Bern
  • John Radcliffe Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

3f Enable Aortic Bioprosthesis Model 6000

Arm Description

Single arm study

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 8, 2010
Last Updated
March 20, 2018
Sponsor
Medtronic Cardiovascular
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1. Study Identification

Unique Protocol Identification Number
NCT01116024
Brief Title
ATS 3f Enable(tm) Aortic Bioprosthesis, Model 6000
Acronym
Enable
Official Title
ATS 3f Enable(tm) Aortic Bioprosthesis, Model 6000
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiovascular

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Valve Diseases
Keywords
Diseased Heart Valve, Replacement, Aortic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
173 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3f Enable Aortic Bioprosthesis Model 6000
Arm Type
Experimental
Arm Description
Single arm study
Intervention Type
Device
Intervention Name(s)
ATS 3f Enable Aortic Bioprosthesis Model 6000
Intervention Description
Replacement Aortic Heart Valve
Primary Outcome Measure Information:
Title
Thromboembolism/Thrombosis
Description
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)
Time Frame
Five Years
Title
Hemorrhage/Bleeding-Anticoagulant/Antiaggregant (All and Major)
Description
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).
Time Frame
Five Years
Title
Paravalvular Leaks (All and Major)
Description
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).
Time Frame
Five Years
Title
Endocarditis
Description
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).
Time Frame
Five Years
Title
Hemolysis
Description
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.
Time Frame
Five Years
Title
Structural Valve Deterioration
Description
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).
Time Frame
Five Years
Title
Non-Structural Dysfunction
Description
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).
Time Frame
Five Years
Title
Re-operation, Explant, Repair
Description
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).
Time Frame
Five Years
Title
Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance
Description
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.
Time Frame
Five Years
Title
Hemodynamic
Description
Mean and peak pressure gradients from discharge through 5 years follow up. The gradient represents the difference in blood pressure across the valve.
Time Frame
Five Years
Title
Hemodynamics - Effective Orifice Area
Description
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.
Time Frame
Five Years
Title
Hemodynamics - Effective Orifice Area Index
Description
The effective orifice area index is a measure of how much the heart valve prosthesis impedes blood flow through the aortic valve.
Time Frame
Five Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Vang
Organizational Affiliation
Medtronic
Official's Role
Study Director
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
Country
Austria
Facility Name
Johann Wolfgang Goethe University
City
Frankfurt
Country
Germany
Facility Name
University Medical Center Freiburg
City
Freiburg
Country
Germany
Facility Name
University Medical Center Kiel
City
Kiel
Country
Germany
Facility Name
UKSH, Campus Lubeck
City
Lubeck
Country
Germany
Facility Name
Medical University of Gdansk
City
Gdansk
Country
Poland
Facility Name
Jagiellonian University
City
Krakow
Country
Poland
Facility Name
Cardiac Surgery University Hospital Basel
City
Basel
Country
Switzerland
Facility Name
Inselspital Bern
City
Bern
Country
Switzerland
Facility Name
John Radcliffe Hospital
City
Oxford
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.medtronic.com/
Description
Medtronic, Inc. Corporate Website

Learn more about this trial

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

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