Recruitment

Recruitment Status
Completed
Estimated Enrollment
20

Inclusion Criteria

An STS score ≥10; or Logistic EuroScore I ≥ 15; or a determination by one cardiovascular surgeon and one cardiologist that the co-morbidities not captured by the STS or EuroScore expected to increase the operative mortality risk to > 15%.
75 years of age or older
Echocardiographic or hemodynamic based evidence of calcific (senile) aortic stenosis with one of the following: aortic valve EOA <1.0 cm2 or 0.6 cm2/m2 , mean aortic valve gradient >40 mmHg or peak aortic valve velocity >4 m/sec
...
An STS score ≥10; or Logistic EuroScore I ≥ 15; or a determination by one cardiovascular surgeon and one cardiologist that the co-morbidities not captured by the STS or EuroScore expected to increase the operative mortality risk to > 15%.
75 years of age or older
Echocardiographic or hemodynamic based evidence of calcific (senile) aortic stenosis with one of the following: aortic valve EOA <1.0 cm2 or 0.6 cm2/m2 , mean aortic valve gradient >40 mmHg or peak aortic valve velocity >4 m/sec
Aortic valve annular diameter ≥ 21 and ≤23mm measured by MSCT
Symptomatology due to aortic stenosis resulting in a New York Heart Association (NYHA) Functional Classification of II or greater
Geographically available, willing to comply with follow up and able to provide written informed consent

Exclusion Criteria

Life expectancy < 1 year due to non-cardiac co-morbid conditions
Hypersensitivity or contraindication to procedural medication and device materials (e.g. titanium, nickel, pork) which cannot be adequately pre-medicated
Need for emergent surgery or intervention other than the investigational procedure
...
Life expectancy < 1 year due to non-cardiac co-morbid conditions
Hypersensitivity or contraindication to procedural medication and device materials (e.g. titanium, nickel, pork) which cannot be adequately pre-medicated
Need for emergent surgery or intervention other than the investigational procedure
Active peptic ulcer or gastrointestinal bleeding within the past 90 days*
Echocardiographic evidence of intracardiac mass, thrombus or vegetation
Severe (Grade 3 to 4) aortic, mitral or tricuspid valve regurgitation
Blood dyscrasias defined as: acute leukopenia, acute anemia, acute thrombocytopenia, history of bleeding diathesis or coagulopathy
Severe pulmonary hypertension with pulmonary systolic pressure greater than two-thirds of systemic pressure
Renal insufficiency as demonstrated by a serum creatinine > 2.5 mg/dL or end stage renal disease requiring chronic dialysis
Stroke or transient ischemic attack within past 6 months*
Myocardial infarction within the past 30 days*
Uncontrolled hypertension (i.e. blood pressure at baseline > 140 mmHg systolic; or in the opinion of the investigator cannot be controlled by medical therapy).
Any therapeutic invasive cardiac procedure performed or planned to perform within 30 days of the index procedure, (or 6 months for drug eluting coronary stent or biventricular pacemaker implantation)*
LVEF < 30%
Patient ineligible for or refuses blood transfusions
Hemodynamic instability requiring inotropic drug therapy within the past 14 days or mechanical support within the past 6 months*
History of any cognitive or mental health status that would interfere with study participation
Active infection requiring ongoing treatment
Unfavorable peripheral vascular anatomy or disease (e.g. severe obstructive calcification, severe tortuosity or small vessels) that would preclude passage of catheters from the femoral arterial access to the aorta as evidenced by peripheral MSCT
Congenital unicuspid or bicuspid aortic valve, or noncalcified aortic valve; or valve eccentricity (calcific or otherwise) that in the opinion of the investigator could compromise procedural success.
Pre-existing prosthetic heart valve in any position, or prosthetic ring
Moderate to severe mitral stenosis
Presence of significant aortic disease such as atheroma, thrombus, or aneurysm which, in the opinion of the investigator, precludes safe implant delivery
Untreated clinically significant coronary artery disease requiring revascularization
Currently participating in any investigational drug or device studies that may confound the results of this study

Summary

Conditions
  • Aortic Valve Stenosis
  • Severe Aortic Stenosis
Type
Interventional
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 75 years and 125 years
Gender
Both males and females

Inclusion Criteria

An STS score ≥10; or Logistic EuroScore I ≥ 15; or a determination by one cardiovascular surgeon and one cardiologist that the co-morbidities not captured by the STS or EuroScore expected to increase the operative mortality risk to > 15%.
75 years of age or older
Echocardiographic or hemodynamic based evidence of calcific (senile) aortic stenosis with one of the following: aortic valve EOA <1.0 cm2 or 0.6 cm2/m2 , mean aortic valve gradient >40 mmHg or peak aortic valve velocity >4 m/sec
...
An STS score ≥10; or Logistic EuroScore I ≥ 15; or a determination by one cardiovascular surgeon and one cardiologist that the co-morbidities not captured by the STS or EuroScore expected to increase the operative mortality risk to > 15%.
75 years of age or older
Echocardiographic or hemodynamic based evidence of calcific (senile) aortic stenosis with one of the following: aortic valve EOA <1.0 cm2 or 0.6 cm2/m2 , mean aortic valve gradient >40 mmHg or peak aortic valve velocity >4 m/sec
Aortic valve annular diameter ≥ 21 and ≤23mm measured by MSCT
Symptomatology due to aortic stenosis resulting in a New York Heart Association (NYHA) Functional Classification of II or greater
Geographically available, willing to comply with follow up and able to provide written informed consent

Exclusion Criteria

Life expectancy < 1 year due to non-cardiac co-morbid conditions
Hypersensitivity or contraindication to procedural medication and device materials (e.g. titanium, nickel, pork) which cannot be adequately pre-medicated
Need for emergent surgery or intervention other than the investigational procedure
...
Life expectancy < 1 year due to non-cardiac co-morbid conditions
Hypersensitivity or contraindication to procedural medication and device materials (e.g. titanium, nickel, pork) which cannot be adequately pre-medicated
Need for emergent surgery or intervention other than the investigational procedure
Active peptic ulcer or gastrointestinal bleeding within the past 90 days*
Echocardiographic evidence of intracardiac mass, thrombus or vegetation
Severe (Grade 3 to 4) aortic, mitral or tricuspid valve regurgitation
Blood dyscrasias defined as: acute leukopenia, acute anemia, acute thrombocytopenia, history of bleeding diathesis or coagulopathy
Severe pulmonary hypertension with pulmonary systolic pressure greater than two-thirds of systemic pressure
Renal insufficiency as demonstrated by a serum creatinine > 2.5 mg/dL or end stage renal disease requiring chronic dialysis
Stroke or transient ischemic attack within past 6 months*
Myocardial infarction within the past 30 days*
Uncontrolled hypertension (i.e. blood pressure at baseline > 140 mmHg systolic; or in the opinion of the investigator cannot be controlled by medical therapy).
Any therapeutic invasive cardiac procedure performed or planned to perform within 30 days of the index procedure, (or 6 months for drug eluting coronary stent or biventricular pacemaker implantation)*
LVEF < 30%
Patient ineligible for or refuses blood transfusions
Hemodynamic instability requiring inotropic drug therapy within the past 14 days or mechanical support within the past 6 months*
History of any cognitive or mental health status that would interfere with study participation
Active infection requiring ongoing treatment
Unfavorable peripheral vascular anatomy or disease (e.g. severe obstructive calcification, severe tortuosity or small vessels) that would preclude passage of catheters from the femoral arterial access to the aorta as evidenced by peripheral MSCT
Congenital unicuspid or bicuspid aortic valve, or noncalcified aortic valve; or valve eccentricity (calcific or otherwise) that in the opinion of the investigator could compromise procedural success.
Pre-existing prosthetic heart valve in any position, or prosthetic ring
Moderate to severe mitral stenosis
Presence of significant aortic disease such as atheroma, thrombus, or aneurysm which, in the opinion of the investigator, precludes safe implant delivery
Untreated clinically significant coronary artery disease requiring revascularization
Currently participating in any investigational drug or device studies that may confound the results of this study

Tracking Information

NCT #
NCT02157142
Collaborators
Not Provided
Investigators
  • Principal Investigator: Axel Linke, MD University of Leipzig - Herzzcntrum
  • Axel Linke, MD University of Leipzig - Herzzcntrum
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