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

Aortic Valve Disease Clinical Trial

Official title:

Catheter-Based Transapical Implantation of the Ventor Embracer™ Heart Valve Prosthesis in Patients With Severe Aortic Valve Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00677638
• Other study ID #: CLIN004
• Status: Active, not recruiting
• Phase: N/A
• First received: May 12, 2008
• Last updated: December 2, 2009
• Start date: June 2008
• Est. completion date: December 2014

Study information

• Verified date: December 2009
• Source: Ventor Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Valve Disease
• Heart Defects, Congenital
• Heart Valve Diseases

Intervention

Device:
• Ventor Embracer
Implantation of Ventor Embracer

Locations

Country	Name	City	State
Germany	Prof. Jochen Schaefers	Homburg
Germany	Prof. Thorsten Wahlers	Koln
Germany	Friedrich Mohr, MD	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
Ventor Technologies

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stable device placement and adequate function as assessed by angiography and echocardiography immediately post-procedure		day one	Yes
Primary	A composite of any death, myocardial infarction, or disabling stroke at 30 days post-procedure		30 days	Yes
Secondary	Device success and the absence of periprocedural MACCEs at post-operative day 1		day one	Yes
Secondary	Any of the following adverse events: death, myocardial infarction, disabling stroke, repeat aortic valve procedure, cardiogenic shock, or endocarditis at 30 days		30 days	Yes
Secondary	Any of the following adverse events: death, disabling stroke, repeat aortic valve procedure or endocarditis at 6 months		6 months	Yes
Secondary	Freedom from death at 1 year		1 year	Yes
Secondary	Functional improvement from baseline per New York Heart Association (NYHA) functional classification at 30 days, 6 months and 1 year		1 year	No
Secondary	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	No