NCT00677638

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2008

Completed
18 days until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 3, 2009

Status Verified

December 1, 2009

Enrollment Period

1.6 years

First QC Date

May 12, 2008

Last Update Submit

December 2, 2009

Conditions

Aortic Valve Disease

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (1)

1

EXPERIMENTAL

Embracer implantation

Device: Ventor Embracer

Interventions

Ventor EmbracerDEVICE

Implantation of Ventor Embracer

1

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patient understands the implications of participating in the study and provides informed consent
  • Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone
  • Age \>75 years
  • 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)
  • Symptoms related to the aortic valve disease, as demonstrated by NYHA Functional Class II or greater
  • EuroSCORE scale of \>9 points indicating a predicted risk for mortality of \>11% according to the logistic EuroSCORE
  • Echocardiographically determined anteroposterior aortic annulus diameter of \>19 and \<23 mm
  • Echocardiographically determined sinotubular junction diameter of ≥23 mm

You may not qualify if:

  • Congenital unicuspid or bicuspid aortic valve
  • Fused commissures
  • Severe eccentricity of calcification
  • Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
  • Severe left ventricular dysfunction (LVEF \< 25%)
  • More than mild right ventricular dysfunction
  • Hypertrophic obstructive cardiomyopathy
  • Moribund patients, or patients with a noncardiac disease limiting by itself life expectancy to less than 12 months
  • Known hypersensitivity or contraindication to any study medication
  • Known sensitivity to contrast medium that cannot be adequately controlled with pre-medication
  • Known allergy or sensitivity to Nitinol
  • Sepsis, or acute endocarditis
  • Blood dyscrasia such as acute anemia, leucopenia, or thrombocytopenia; bleeding diathesis, or coagulopathy.
  • Renal insufficiency and/or end stage renal disease requiring chronic dialysis
  • 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).
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Prof. Thorsten Wahlers

Cologne, 50924, Germany

Location

Prof. Jochen Schaefers

Homburg, 66421, Germany

Location

Friedrich Mohr, MD

Leipzig, 04289, Germany

Location

Related Publications (1)

  • 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.

    PMID: 21148541DERIVED

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Jochen Schaefers, MD

    Universitatsklinikum des Saarlandes

    PRINCIPAL INVESTIGATOR

  • Friedrich Mohr, MD

    Universität Leipzig

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 12, 2008

First Posted

May 14, 2008

Study Start

June 1, 2008

Primary Completion

January 1, 2010

Study Completion

December 1, 2014

Last Updated

December 3, 2009

Record last verified: 2009-12

Locations

DE(3)