Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Ventor Technologies
ClinicalTrials.gov Identifier:
NCT00677638
First received: May 12, 2008
Last updated: December 2, 2009
Last verified: December 2009
History of Changes
  Purpose

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 Intervention
Aortic Valve Disease
 Device: Ventor Embracer

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Further study details as provided by Ventor Technologies:

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

Secondary Outcome Measures:
  • Device success and the absence of periprocedural MACCEs at post-operative day 1 [ Time Frame: day one ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Any of the following adverse events: death, disabling stroke, repeat aortic valve procedure or endocarditis at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Freedom from death at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Functional improvement from baseline per New York Heart Association (NYHA) functional classification at 30 days, 6 months and 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Embracer implantation
 Device: Ventor Embracer
Implantation of Ventor Embracer

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00677638

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

No publications provided by Ventor Technologies

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sharon Sax, Ventor Technologies
ClinicalTrials.gov Identifier: NCT00677638     History of Changes
Other Study ID Numbers: CLIN004
Study First Received: May 12, 2008
Last Updated: December 2, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on May 16, 2013