Status:
COMPLETED
ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis (2011-03)
Lead Sponsor:
Symetis SA
Conditions:
Aortic Stenosis Symptomatic
Eligibility:
All Genders
75+ years
Phase:
NA
Brief Summary
First-In-Man Study on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation in Patients with Severe Aortic Stenosis to collect human feasibility data pertaining to the safety and performance ...
Detailed Description
A single arm, prospective, multicenter, non-randomized, open trial, up to 5 Years follow-up with the Symetis ACURATE TF™ Transfemoral Aortic Bioprosthesis for minimal invasive implantation via transfe...
Eligibility Criteria
Inclusion
- Patients 75 years of age and older
- Logistic EuroSCORE ≥ 20%
- Severe aortic stenosis characterized by mean aortic gradient \> 40 mmHg or peak jet velocity \> 4.0 m/s or aortic valve area \< 1.0 cm2
- New York Heart Association (NYHA) Functional Class \> II
- Aortic annulus diameter from ≥ 21mm up to ≤ 27mm measured by TEE
- Patient not a surgical candidate due to significant co-morbid conditions unrelated to aortic stenosis
- Patient willing to participate in the study and provide signed informed consent
Exclusion
- Unicuspid or bicuspid aortic valve
- Extreme eccentricity of calcification
- Severe mitral regurgitation ( \>2+)
- Pre-existing prosthetic heart valve in any position and / or prosthetic ring
- Aortic or peripheral anatomy NOT appropriate for transfemoral implant
- Thoracic (TAA) or abdominal (AAA) aortic aneurysm
- Presence of endovascular stent graft for treatment of TAA or AAA
- Trans-esophageal echocardiogram (TEE) is contraindicated
- Left Ventricle Ejection Fraction (LVEF) \< 30% by echocardiography (ECHO)
- ECHO evidence of intracardiac mass, thrombus, or vegetation
- Acute Myocardial Infarction (AMI) within 1 month prior to implant procedure
- Percutaneous Coronary Intervention (PCI), except for balloon valvuloplasty (BAV) within 1 month prior to implant procedure
- Previous Transient Ischemic Attack (TIA) or stroke within 3 months prior to implant procedure
- Active ulcer or gastrointestinal (GI) bleeding within 3 months prior to implant procedure
- Any scheduled surgical or percutaneous procedure to be performed prior to 30 day visit
- History of bleeding diathesis or coagulopathy or refusal of blood transfusions
- Systolic pressure \<80 mmHg, cardiogenic shock, need for inotropic support or Intra-Aortic Balloon Pump (IABP)
- Primary hypertrophic obstructive cardiomyopathy (HOCM)
- Active infection, endocarditis or pyrexia
- Hepatic failure
- Chronic renal dysfunction with serum creatinine \> 2.5 mg/dL or renal dialysis
- Refusal of surgery
- Severe Chronic Obstruction Pulmonary Disease (COPD) requiring home oxygen
- Neurological disease severely affecting ambulation or daily functioning, or dementia
- Life expectancy \< 12 months due to non-cardiac co-morbid conditions
- Known hypersensitivity/contraindication to study medication, contrast media, or nitinol
- Currently participating in an investigational drug or another device study
Key Trial Info
Start Date :
May 9 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2022
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03752996
Start Date
May 9 2012
End Date
March 30 2022
Last Update
February 23 2023
Active Locations (5)
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1
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil, CEP 04012-909
2
Kerckhoff Klinik GmbH
Bad Nauheim, Germany, 61231
3
Universitätsklinikum Bonn
Bonn, Germany, 53105
4
Herzzentrum Universitätsklinikum Köln
Cologne, Germany, 50937