Heart Valve DiseasesEnableNCT01116024
ATS 3f Enable(tm) Aortic Bioprosthesis, Model 6000
A study testing ATS 3f Enable Aortic Bioprosthesis Model 6000 in people with Heart Valve Diseases, run by Medtronic Cardiovascular at 10 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Valve Diseases
- What is being tested?
- ATS 3f Enable Aortic Bioprosthesis Model 6000
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 10 sitesin 5 countries
- Study dates
- May 2006to Aug 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
10 sites in 5 countries.
10 sites in 5 countries
Germany4 sites
Johann Wolfgang Goethe University
Frankfurt
University Medical Center Freiburg
Freiburg im Breisgau
University Medical Center Kiel
Kiel
UKSH, Campus Lubeck
Lübeck
Poland2 sites
Medical University of Gdansk
Gdansk
Jagiellonian University
Krakow
Switzerland2 sites
Cardiac Surgery University Hospital Basel
Basel
Inselspital Bern
Bern
About this study
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.
Read the 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.
- Conditions
- Heart Valve Diseases
- Being tested
- ATS 3f Enable Aortic Bioprosthesis Model 6000
- Keywords
- Diseased Heart Valve, Replacement, Aortic
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATS 3f Enable Aortic Bioprosthesis Model 6000Device
Replacement Aortic Heart Valve
| Study group | Role | What they receive |
|---|---|---|
| 3f Enable Aortic Bioprosthesis Model 6000 | Experimental | Single arm study Receives: Device: ATS 3f Enable Aortic Bioprosthesis Model 6000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Five Years
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).
Measured: Five Years
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).
Measured: Five Years
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).
Measured: Five Years
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.
Measured: Five Years
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).
Measured: Five Years
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).
Measured: Five Years
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).
Measured: Five Years
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.
Measured: Five Years
Hemodynamic
Mean and peak pressure gradients from discharge through 5 years follow up. The gradient represents the difference in blood pressure across the valve.
Measured: Five Years
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.
Measured: Five Years
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.
Measured: Five Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startMay 2006
- Primary completionDec 2010
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart Valve DiseasesStudies of the same condition, open and under way.
- More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Vang, Study director, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116024
- Sponsor's protocol ID
- S2005 Rev. 17-MAY-2007
- Acronym
- Enable
- Status last verified
- Oct 2017
- First submitted
- 8 Apr 2010
- Last updated
- 26 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ATS 3f Enable(tm) Aortic Bioprosthesis, Model 6000
- ClinicalTrials.gov ID
- NCT01116024
- Acronym / sponsor ID
- Enable / S2005 Rev. 17-MAY-2007
- Conditions
- Heart Valve Diseases
- Keywords
- Diseased Heart Valve, Replacement, Aortic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Medtronic CardiovascularIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 4 May 2010 (estimated)
- Results
- Posted 5 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3f Enable Aortic Bioprosthesis Model 6000 | Experimental | Device: ATS 3f Enable Aortic Bioprosthesis Model 6000Single arm study |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATS 3f Enable Aortic Bioprosthesis Model 6000Replacement Aortic Heart Valve | Device | 3f Enable Aortic Bioprosthesis Model 6000 |
Primary outcome
Thromboembolism/Thrombosis
Time frame: Five Years
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
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
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
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
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
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
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
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
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
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
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
The effective orifice area index is a measure of how much the heart valve prosthesis impedes blood flow through the aortic valve.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Medtronic, Inc. Corporate WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Vang study director
Medtronic
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATS 3f Enable Aortic Bioprosthesis Model 6000 in people with Heart Valve Diseases, run by Medtronic Cardiovascular at 10 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Poland, Switzerland, Austria, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thromboembolism/Thrombosis (time frame: Five Years). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.