Transapical Implantation of Ventor Embracer™ Valve in Patients With Severe Aortic Valve Disease
NCT ID: NCT00677638
Last Updated: 2009-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2008-06-30
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Embracer implantation
Ventor Embracer
Implantation of Ventor Embracer
Interventions
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Ventor Embracer
Implantation of Ventor Embracer
Eligibility Criteria
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Inclusion Criteria
2. Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone
3. Age \>75 years
4. 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)
5. Symptoms related to the aortic valve disease, as demonstrated by NYHA Functional Class II or greater
6. EuroSCORE scale of \>9 points indicating a predicted risk for mortality of \>11% according to the logistic EuroSCORE
7. Echocardiographically determined anteroposterior aortic annulus diameter of \>19 and \<23 mm
8. Echocardiographically determined sinotubular junction diameter of ≥23 mm
Exclusion Criteria
2. Fused commissures
3. Severe eccentricity of calcification
4. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
5. Severe left ventricular dysfunction (LVEF \< 25%)
6. More than mild right ventricular dysfunction
7. Hypertrophic obstructive cardiomyopathy
8. Moribund patients, or patients with a noncardiac disease limiting by itself life expectancy to less than 12 months
9. Known hypersensitivity or contraindication to any study medication
10. Known sensitivity to contrast medium that cannot be adequately controlled with pre-medication
11. Known allergy or sensitivity to Nitinol
12. Sepsis, or acute endocarditis
13. Blood dyscrasia such as acute anemia, leucopenia, or thrombocytopenia; bleeding diathesis, or coagulopathy.
14. Renal insufficiency and/or end stage renal disease requiring chronic dialysis
15. 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).
16. Significant lung disease (e.g. FEV1 \< 1.2L or FEV1 \< 50%).
17. Active peptic ulcer or GI bleeding within 3 months from the planned index procedure
18. Untreated clinically significant coronary artery disease requiring revascularisation
19. Cardiogenic shock, suspected cardiogenic shock, or hemodynamic instability requiring inotropic support or mechanical heart assistance
20. Peripheral vascular disease, including abdominal and thoracic aortic disease, which could pose a problem for eventual transarterial mechanical support (e.g. Intraaortic Balloon Pump)
21. Need for emergency surgery, cardiac or noncardiac
22. History of myocardial infarction in the last 6 weeks.
23. History of TIA or stroke in the last 6 months.
24. 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.
25. Uncontrolled atrial fibrillation
26. Pre-existing aortic valve replacement
27. Severe (greater than 3+) mitral regurgitation
28. Severe (greater than 3+) aortic regurgitation
29. Patient is currently enrolled in another investigational device or drug trial
75 Years
ALL
No
Sponsors
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Ventor Technologies
INDUSTRY
Responsible Party
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Ventor Technologies
Principal Investigators
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Jochen Schaefers, MD
Role: PRINCIPAL_INVESTIGATOR
Universitatsklinikum des Saarlandes
Friedrich Mohr, MD
Role: PRINCIPAL_INVESTIGATOR
Universität Leipzig
Locations
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Prof. Thorsten Wahlers
Cologne, , Germany
Prof. Jochen Schaefers
Homburg, , Germany
Friedrich Mohr, MD
Leipzig, , Germany
Countries
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References
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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.
Other Identifiers
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CLIN004
Identifier Type: -
Identifier Source: org_study_id