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Transapical Implantation of Ventor Embracer™ Valve in Patients With Severe Aortic Valve Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00677638
Recruitment Status : Unknown
Verified December 2009 by Ventor Technologies.
Recruitment status was:  Active, not recruiting
First Posted : May 14, 2008
Last Update Posted : December 3, 2009
Information provided by:
Ventor Technologies

Brief 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.

Condition or disease Intervention/treatment Phase
Aortic Valve Disease Device: Ventor Embracer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Catheter-Based Transapical Implantation of the Ventor Embracer™ Heart Valve Prosthesis in Patients With Severe Aortic Valve Disease
Study Start Date : June 2008
Estimated Primary Completion Date : January 2010
Estimated Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: 1
Embracer implantation
Device: Ventor Embracer
Implantation of Ventor Embracer

Primary Outcome Measures :
  1. Stable device placement and adequate function as assessed by angiography and echocardiography immediately post-procedure [ Time Frame: day one ]
  2. A composite of any death, myocardial infarction, or disabling stroke at 30 days post-procedure [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Device success and the absence of periprocedural MACCEs at post-operative day 1 [ Time Frame: day one ]
  2. Any of the following adverse events: death, myocardial infarction, disabling stroke, repeat aortic valve procedure, cardiogenic shock, or endocarditis at 30 days [ Time Frame: 30 days ]
  3. Any of the following adverse events: death, disabling stroke, repeat aortic valve procedure or endocarditis at 6 months [ Time Frame: 6 months ]
  4. Freedom from death at 1 year [ Time Frame: 1 year ]
  5. Functional improvement from baseline per New York Heart Association (NYHA) functional classification at 30 days, 6 months and 1 year [ Time Frame: 1 year ]
  6. 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 [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient understands the implications of participating in the study and provides informed consent
  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:

  1. Congenital unicuspid or bicuspid aortic valve
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00677638

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Prof. Jochen Schaefers
Homburg, Germany, 66421
Prof. Thorsten Wahlers
Koln, Germany, 50924
Friedrich Mohr, MD
Leipzig, Germany, 04289
Sponsors and Collaborators
Ventor Technologies
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Principal Investigator: Jochen Schaefers, MD Universitatsklinikum des Saarlandes
Principal Investigator: Friedrich Mohr, MD Universität Leipzig

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sharon Sax, Ventor Technologies Identifier: NCT00677638     History of Changes
Other Study ID Numbers: CLIN004
First Posted: May 14, 2008    Key Record Dates
Last Update Posted: December 3, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
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Heart Defects, Congenital
Heart Valve Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities