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

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.

Study Overview

• Status: Unknown
• Conditions: Aortic Valve Disease
• Intervention / Treatment: Device: Ventor Embracer

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Homburg, Germany, 66421
    • Prof. Jochen Schaefers
  • Koln, Germany, 50924
    • Prof. Thorsten Wahlers
  • Leipzig, Germany, 04289
    • Friedrich Mohr, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Embracer implantation	Device: Ventor Embracer; Implantation of Ventor Embracer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Stable device placement and adequate function as assessed by angiography and echocardiography immediately post-procedure	day one
A composite of any death, myocardial infarction, or disabling stroke at 30 days post-procedure	30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ventor Technologies
• Investigators: Principal Investigator: Jochen Schaefers, MD, Universitätsklinikum des Saarlandes; Principal Investigator: Friedrich Mohr, MD, Universität Leipzig

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Anticipated): January 1, 2010
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: May 12, 2008
• First Submitted That Met QC Criteria: May 12, 2008
• First Posted (Estimate): May 14, 2008

Study Record Updates

• Last Update Posted (Estimate): December 3, 2009
• Last Update Submitted That Met QC Criteria: December 2, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital; Heart Valve Diseases; Aortic Valve Disease
• Other Study ID Numbers: CLIN004