Aortic Valve StenosisNCT01348438
Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System - The Engager European Pivotal Trial
A study testing Medtronic Engager Transcatheter Aortic Valve Implantation System in people with Aortic Valve Stenosis, run by Medtronic Cardiac Rhythm and Heart Failure at 9 sites in 4 countries.
Trial summary
The purpose of the study is to evaluate the safety and clinical performance of the Engager Transcatheter Aortic Valve Implantation System in patients with severe aortic valve stenosis who are at high risk for surgical valve replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Medtronic Engager Transcatheter Aortic Valve Implantation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 12 Sep 2011to 25 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe aortic stenosis defined as one or more of the following by Doppler echocardiography: mean gradient > 40 mmHg; max velocity > 4m/s; aortic valve area ≤ 0.8 cm2.
- Symptoms related to aortic valve disease, and NYHA Functional Class II or greater.
- Logistic EuroSCORE predicted risk for mortality of ≥20%, or comorbidity judged by the investigator to pose an absolute or relative contraindication for conventional aortic valve replacement.
- Patient is indicated for aortic valve implantation with a biological prosthesis (tissue valve) in accordance with the 2007 European Society of Cardiology (ESC) Guidelines for management of valvular heart disease.
- Age ≥ 18 years.
- Echocardiographically determined aortic annulus diameter of ≥19 mm and ≤ 26 mm in a long-axis view.
Who cannot join
- Congenital unicuspid or bicuspid aortic valve.
- Severe eccentricity of calcification, defined as calcium deposits larger than 6mm in diameter.
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
- Left ventricular ejection fraction < 25%, as determined by contrast ventriculography, or echocardiography or radionuclide angiography if contrast ventriculography not available
- Hypertrophic obstructive cardiomyopathy.
- Patients with life expectancy less than 12 months due to an underlying non-cardiac comorbid disease.
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- Known hypersensitivity or contraindication that cannot be adequately controlled with pre-medication to any study medication or material, such as contrast medium or Nitinol.
- Sepsis or acute endocarditis.
- Blood dyscrasia such as acute anemia, leucopenia, or thrombocytopenia; bleeding diathesis, or coagulopathy.
- Renal insufficiency assessed by creatinine > 2.5 mg/dl and/or end stage renal disease requiring chronic dialysis.
- Active peptic ulcer or GI bleeding within 3 months from the planned index procedure.
- Untreated clinically significant coronary artery disease requiring revascularization.
- Cardiogenic shock, suspected cardiogenic shock, or hemodynamic instability requiring inotropic support or mechanical heart assistance.
- Significant aortic disease, including abdominal and thoracic aortic aneurysm, defined as maximal luminal diameter of 5 cm or greater.
- Need for emergency surgery, cardiac or non-cardiac.
- History of myocardial infarction in the last 6 weeks.
- History of TIA or CVA in the last 6 months.
- Therapeutic invasive cardiac procedure, with the exception of aortic balloon valvuloplasty, performed within 30 days of the planned date of valve implantation, or 6 months in the case of drug-eluting stents.
- Pre-existing prosthetic heart valve or prosthetic ring in any position.
- Mitral regurgitation greater than 2+ by angiography or moderate by echocardiography.
- Patient refuses a blood transfusion.
- Patient is currently enrolled in another investigational device or drug trial that may influence the outcome of this trial.
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Germany6 sites
Kerckhoff-Klinik
Bad Nauheim, 61231
Ruhr-Universität Bochum
Bad Oeynhausen, 32545
Uniklinik Köln Heart Center
Cologne, 50937
Universitätsklinikum Hamburg- Eppendorf
Hamburg, 20246
Herzzentrum Leipzig GmbH
Leipzig, 04289
Deutsches Herzzentrum München
München, 80636
Switzerland1 site
University of Zurich - Klinik für Herzchirurgie, UniversitätsSpital
Zurich, 8091
About this study
The purpose of the study is to evaluate the safety and clinical performance of the Engager Transcatheter Aortic Valve Implantation System in patients with severe aortic valve stenosis who are at high risk for surgical valve replacement.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Medtronic Engager Transcatheter Aortic Valve Implantation System
- Keywords
- high risk, surgical valve replacement
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Engager Transcatheter Aortic Valve Implantation SystemDevice
Transapical implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System
| Study group | Role | What they receive |
|---|---|---|
| Single arm study | Other | Not described Receives: Device: Medtronic Engager Transcatheter Aortic Valve Implantation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
All-cause mortality within 30 days post-implantation
Measured: 30 Days
Secondary outcomes (2)
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) free survival at 30 days and 6 months post implantation
Measured: 6 months
Device and procedure related Major Adverse Events
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study start12 Sep 2011
- Primary completion28 Feb 2013
- Study completion25 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe 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
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Volkmar Falk, Prof., Principal investigator, University of ZurichJean-Louis Vanoverschelde, Prof., Principal investigator, Cliniques Universitaires Saint-Luc, Brussels
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348438
- Sponsor's protocol ID
- ENG CIP-001
- Status last verified
- Sep 2018
- First submitted
- 4 May 2011
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Holzhey D, Linke A, Treede H, Baldus S, Bleiziffer S, Wagner A, Borgermann J, Scholtz W, Vanoverschelde JL, Falk V. Intermediate follow-up results from the multicenter engager European pivotal trial. Ann Thorac Surg. 2013 Dec;96(6):2095-100. doi: 10.1016/j.athoracsur.2013.06.089. Epub 2013 Sep 7.
PubMed 24021766
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System - The Engager European Pivotal Trial
- ClinicalTrials.gov ID
- NCT01348438
- Acronym / sponsor ID
- ENG CIP-001
- Conditions
- Aortic Valve Stenosis
- Keywords
- high risk, surgical valve replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2011 (actual)
- Primary completion
- 28 Feb 2013 (actual)
- Study completion
- 25 Jan 2018 (actual)
- First posted
- 5 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the safety and clinical performance of the Engager Transcatheter Aortic Valve Implantation System in patients with severe aortic valve stenosis who are at high risk for surgical valve replacement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm study | Other | Device: Medtronic Engager Transcatheter Aortic Valve Implantation System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Severe aortic stenosis defined as one or more of the following by Doppler echocardiography: mean gradient > 40 mmHg; max velocity > 4m/s; aortic valve area ≤ 0.8 cm2.
- Symptoms related to aortic valve disease, and NYHA Functional Class II or greater.
- Logistic EuroSCORE predicted risk for mortality of ≥20%, or comorbidity judged by the investigator to pose an absolute or relative contraindication for conventional aortic valve replacement.
- Patient is indicated for aortic valve implantation with a biological prosthesis (tissue valve) in accordance with the 2007 European Society of Cardiology (ESC) Guidelines for management of valvular heart disease.
- Age ≥ 18 years.
Key exclusion criteria (22 listed)
- Congenital unicuspid or bicuspid aortic valve.
- Severe eccentricity of calcification, defined as calcium deposits larger than 6mm in diameter.
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
- Left ventricular ejection fraction < 25%, as determined by contrast ventriculography, or echocardiography or radionuclide angiography if contrast ventriculography not available
- Hypertrophic obstructive cardiomyopathy.
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 |
|---|---|---|
| Medtronic Engager Transcatheter Aortic Valve Implantation SystemTransapical implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System | Device | Single arm study |
Primary outcome
All-cause mortality
Time frame: 30 Days
All-cause mortality within 30 days post-implantation
2 secondary outcomes
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) free survival at 30 days and 6 months post implantation
Time frame: 6 months
Device and procedure related Major Adverse Events
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Derived from this study: PubMed 24021766Holzhey D, Linke A, Treede H, Baldus S, Bleiziffer S, Wagner A, Borgermann J, Scholtz W, Vanoverschelde JL, Falk V. Intermediate follow-up results from the multicenter engager European pivotal trial. Ann Thorac Surg. 2013 Dec;96(6):2095-100. doi: 10.1016/j.athoracsur.2013.06.089. Epub 2013 Sep 7.
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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.
Volkmar Falk, Prof. principal investigator
University of Zurich
Jean-Louis Vanoverschelde, Prof. principal investigator
Cliniques Universitaires Saint-Luc, Brussels
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Engager Transcatheter Aortic Valve Implantation System in people with Aortic Valve Stenosis, run by Medtronic Cardiac Rhythm and Heart Failure at 9 sites in 4 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 6 inclusion and 22 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 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Belgium, Israel, Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
All-cause mortality (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01348438, which also lists 1 linked publication.
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 18 Sep 2018.