Aortic Valve DiseaseNCT00677638
Transapical Implantation of Ventor Embracer™ Valve in Patients With Severe Aortic Valve Disease
A study testing Ventor Embracer in people with Aortic Valve Disease, run by Ventor Technologies at 3 sites in Germany.
Trial summary
A prospective single arm study evaluating feasibility and safety of a catheter-based transapical implantation of the Ventor Embracer™ aortic valve bioprosthesis in patients with severe aortic valve disease, specifically aortic stenosis, who are at elevated risk for standard surgical valve replacement. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Aortic Valve Disease
- What is being tested?
- Ventor Embracer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesGermany
- Study dates
- Jun 2008to Dec 2014
- Phase
- Interventional
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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient understands the implications of participating in the study and provides informed consent
- Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone
- Age >75 years
- Severe, aortic stenosis (echocardiographically derived mean gradient > 40 mm Hg, and/or jet velocity > 4m/s, or an initial aortic valve area of < 0.8 cm2)
- Symptoms related to the aortic valve disease, as demonstrated by NYHA Functional Class II or greater
- EuroSCORE scale of >9 points indicating a predicted risk for mortality of >11% according to the logistic EuroSCORE
- Echocardiographically determined anteroposterior aortic annulus diameter of >19 and <23 mm
- Echocardiographically determined sinotubular junction diameter of ≥23 mm
Who cannot join
- Congenital unicuspid or bicuspid aortic valve
- Fused commissures
- Severe eccentricity of calcification
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
- Severe left ventricular dysfunction (LVEF < 25%)
- More than mild right ventricular dysfunction
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- Hypertrophic obstructive cardiomyopathy
- Moribund patients, or patients with a noncardiac disease limiting by itself life expectancy to less than 12 months
- Known hypersensitivity or contraindication to any study medication
- Known sensitivity to contrast medium that cannot be adequately controlled with pre-medication
- Known allergy or sensitivity to Nitinol
- Sepsis, or acute endocarditis
- Blood dyscrasia such as acute anemia, leucopenia, or thrombocytopenia; bleeding diathesis, or coagulopathy.
- Renal insufficiency and/or end stage renal disease requiring chronic dialysis
- Liver disease as indicated by jaundice, ascites, ALT/AST > 3 x ULN, elevation of total bilirubin > 1.5 mg/dl, albumin < 3.0 g/l, or INR > 1.5 (if not on anticoagulation).
- Significant lung disease (e.g. FEV1 < 1.2L or FEV1 < 50%).
- Active peptic ulcer or GI bleeding within 3 months from the planned index procedure
- Untreated clinically significant coronary artery disease requiring revascularisation
- Cardiogenic shock, suspected cardiogenic shock, or hemodynamic instability requiring inotropic support or mechanical heart assistance
- Peripheral vascular disease, including abdominal and thoracic aortic disease, which could pose a problem for eventual transarterial mechanical support (e.g. Intraaortic Balloon Pump)
- Need for emergency surgery, cardiac or noncardiac
- History of myocardial infarction in the last 6 weeks.
- History of TIA or stroke in the last 6 months.
- Any therapeutic invasive cardiac procedure, except aortic balloon valvuloplasty, performed within 30 days from the planned index procedure, or 6 months, in case of implantation of drug-eluting stents.
- Uncontrolled atrial fibrillation
- Pre-existing aortic valve replacement
- Severe (greater than 3+) mitral regurgitation
- Severe (greater than 3+) aortic regurgitation
- Patient is currently enrolled in another investigational device or drug trial
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Prof. Thorsten Wahlers
Cologne, 50924
Prof. Jochen Schaefers
Homburg, 66421
Friedrich Mohr, MD
Leipzig, 04289
About this study
Official title: Catheter-Based Transapical Implantation of the Ventor Embracer™ Heart Valve Prosthesis in Patients With Severe Aortic Valve Disease
A prospective single arm study evaluating feasibility and safety of a catheter-based transapical implantation of the Ventor Embracer™ aortic valve bioprosthesis in patients with severe aortic valve disease, specifically aortic stenosis, who are at elevated risk for standard surgical valve replacement.
- Conditions
- Aortic Valve Disease
- Being tested
- Ventor Embracer
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventor EmbracerDevice
Implantation of Ventor Embracer
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Embracer implantation Receives: Device: Ventor Embracer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stable device placement and adequate function as assessed by angiography and echocardiography immediately post-procedure
Measured: day one
A composite of any death, myocardial infarction, or disabling stroke at 30 days post-procedure
Measured: 30 days
Secondary outcomes (6)
Device success and the absence of periprocedural MACCEs at post-operative day 1
Measured: day one
Any of the following adverse events: death, myocardial infarction, disabling stroke, repeat aortic valve procedure, cardiogenic shock, or endocarditis at 30 days
Measured: 30 days
Any of the following adverse events: death, disabling stroke, repeat aortic valve procedure or endocarditis at 6 months
Measured: 6 months
Freedom from death at 1 year
Measured: 1 year
Functional improvement from baseline per New York Heart Association (NYHA) functional classification at 30 days, 6 months and 1 year
Measured: 1 year
Peak & mean pressure gradient, derived calculated measures of prosthetic valve function, aortic regurgitation - assessed by echocardiography immediately after deployment, at POD 1, 30 days, 6 months and 5 years annually
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2008 (estimated)
- Study startJun 2008
- Primary completionJan 2010 (estimated)
- Study completionDec 2014 (estimated)
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 DiseaseStudies of the same condition, open and under way.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ventor Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jochen Schaefers, MD, Principal investigator, Universitatsklinikum des SaarlandesFriedrich Mohr, MD, Principal investigator, Universität Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677638
- Sponsor's protocol ID
- CLIN004
- Status last verified
- Dec 2009
- First submitted
- 12 May 2008
- Last updated
- 3 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Falk V, Walther T, Schwammenthal E, Strauch J, Aicher D, Wahlers T, Schafers J, Linke A, Mohr FW. Transapical aortic valve implantation with a self-expanding anatomically oriented valve. Eur Heart J. 2011 Apr;32(7):878-87. doi: 10.1093/eurheartj/ehq445. Epub 2010 Dec 9.
PubMed 21148541