HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 20
Inclusion Criteria
- Symptomatology due to aortic stenosis resulting in a New York Heart Association (NYHA) Functional Classification of II or greater
- 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
- 75 years of age or older
- ...
- Symptomatology due to aortic stenosis resulting in a New York Heart Association (NYHA) Functional Classification of II or greater
- 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
- 75 years of age or older
- Aortic valve annular diameter ≥ 21 and ≤23mm measured by MSCT
- 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%.
- Geographically available, willing to comply with follow up and able to provide written informed consent
Exclusion Criteria
- Need for emergent surgery or intervention other than the investigational procedure
- Patient ineligible for or refuses blood transfusions
- LVEF < 30%
- ...
- Need for emergent surgery or intervention other than the investigational procedure
- Patient ineligible for or refuses blood transfusions
- LVEF < 30%
- Myocardial infarction within the past 30 days*
- Presence of significant aortic disease such as atheroma, thrombus, or aneurysm which, in the opinion of the investigator, precludes safe implant delivery
- Hemodynamic instability requiring inotropic drug therapy within the past 14 days or mechanical support within the past 6 months*
- Life expectancy < 1 year due to non-cardiac co-morbid conditions
- 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
- Untreated clinically significant coronary artery disease requiring revascularization
- Severe pulmonary hypertension with pulmonary systolic pressure greater than two-thirds of systemic pressure
- History of any cognitive or mental health status that would interfere with study participation
- Active infection requiring ongoing treatment
- Uncontrolled hypertension (i.e. blood pressure at baseline > 140 mmHg systolic; or in the opinion of the investigator cannot be controlled by medical therapy).
- Severe (Grade 3 to 4) aortic, mitral or tricuspid valve regurgitation
- Renal insufficiency as demonstrated by a serum creatinine > 2.5 mg/dL or end stage renal disease requiring chronic dialysis
- 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.
- Stroke or transient ischemic attack within past 6 months*
- Blood dyscrasias defined as: acute leukopenia, acute anemia, acute thrombocytopenia, history of bleeding diathesis or coagulopathy
- Currently participating in any investigational drug or device studies that may confound the results of this study
- 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)*
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- Moderate to severe mitral stenosis
- Hypersensitivity or contraindication to procedural medication and device materials (e.g. titanium, nickel, pork) which cannot be adequately pre-medicated
- Active peptic ulcer or gastrointestinal bleeding within the past 90 days*
- Pre-existing prosthetic heart valve in any position, or prosthetic ring
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
- Symptomatology due to aortic stenosis resulting in a New York Heart Association (NYHA) Functional Classification of II or greater
- 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
- 75 years of age or older
- ...
- Symptomatology due to aortic stenosis resulting in a New York Heart Association (NYHA) Functional Classification of II or greater
- 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
- 75 years of age or older
- Aortic valve annular diameter ≥ 21 and ≤23mm measured by MSCT
- 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%.
- Geographically available, willing to comply with follow up and able to provide written informed consent
Exclusion Criteria
- Need for emergent surgery or intervention other than the investigational procedure
- Patient ineligible for or refuses blood transfusions
- LVEF < 30%
- ...
- Need for emergent surgery or intervention other than the investigational procedure
- Patient ineligible for or refuses blood transfusions
- LVEF < 30%
- Myocardial infarction within the past 30 days*
- Presence of significant aortic disease such as atheroma, thrombus, or aneurysm which, in the opinion of the investigator, precludes safe implant delivery
- Hemodynamic instability requiring inotropic drug therapy within the past 14 days or mechanical support within the past 6 months*
- Life expectancy < 1 year due to non-cardiac co-morbid conditions
- 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
- Untreated clinically significant coronary artery disease requiring revascularization
- Severe pulmonary hypertension with pulmonary systolic pressure greater than two-thirds of systemic pressure
- History of any cognitive or mental health status that would interfere with study participation
- Active infection requiring ongoing treatment
- Uncontrolled hypertension (i.e. blood pressure at baseline > 140 mmHg systolic; or in the opinion of the investigator cannot be controlled by medical therapy).
- Severe (Grade 3 to 4) aortic, mitral or tricuspid valve regurgitation
- Renal insufficiency as demonstrated by a serum creatinine > 2.5 mg/dL or end stage renal disease requiring chronic dialysis
- 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.
- Stroke or transient ischemic attack within past 6 months*
- Blood dyscrasias defined as: acute leukopenia, acute anemia, acute thrombocytopenia, history of bleeding diathesis or coagulopathy
- Currently participating in any investigational drug or device studies that may confound the results of this study
- 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)*
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- Moderate to severe mitral stenosis
- Hypersensitivity or contraindication to procedural medication and device materials (e.g. titanium, nickel, pork) which cannot be adequately pre-medicated
- Active peptic ulcer or gastrointestinal bleeding within the past 90 days*
- Pre-existing prosthetic heart valve in any position, or prosthetic ring
Tracking Information
- NCT #
- NCT02157142
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Axel Linke, MD University of Leipzig - Herzzcntrum
- Axel Linke, MD University of Leipzig - Herzzcntrum