Clinical trial NCT03143673: ACURATE™ Transapical Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis (2010-01)
Official title: ACURATE™ Transapical Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Symptomatic Stenosis
Keywords: Severe Symptomatic Aortic Valve Stenosis
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2017-05-08
Enrollment: 50
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate safety of the study device and study device performance in patients presenting with severe aortic stenosis who are considered to be high risk for open surgical repair.

Detailed description: A single arm, prospective, multicenter, non-randomized, and open trial, up to 5 years follow-up with the Symetis ACURATE TA™ which is an aortic bioprosthesis for minimal invasive implantation vie transapical access to treat patients with severe symptomatic aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be associated with high surgical risk for evaluating safety and performance of the implantation and safety at 30-D follow-up.

Eligibility criteria: Inclusion Criteria:

1. Patients at least 75 years of age
2. Additive EuroSCORE \> 9
3. Severe AS assessed by echocardiography and documented by a mean gradient \> 40mmHg and a native Aortic Valve Area (AVA) \< 0.8 cm² or Aortic Valve Area Index (AVAI) \< 0.6 cm²/m²
4. NYHA Functional Class \> II
5. Aortic annulus (AAn) diameters between and including 21 mm up to 27 mm (21mm ≤ AAn ≤27mm) by transoesophageal echocardiography (TEE)
6. Patient understands the implications of participating in the study and provides signed informed consent

Exclusion Criteria:

1. Congenital unicuspid or bicuspid aortic valve
2. Severe eccentricity of calcification
3. Severe mitral regurgitation (\> 2°)
4. Pre-existing prosthetic heart valve in any position and / or prosthetic ring
5. Severe transapical access problem, non-reachable LV apex
6. Previous surgery of the LV using a patch, such as the Dor procedure
7. Presence of apical LV thrombus
8. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
9. Acute myocardial infarction (AMI) within 1 month prior to the procedure
10. PCI within 1 month prior to the procedure
11. Previous transient ischemic attack (TIA) or stroke in the last 3 months
12. Untreated clinically significant coronary artery disease (CAD) requiring revascularization
13. Hemodynamic instability: systolic pressure \<90mmHg without afterload reduction, shock, need for inotropic support or intra-aortic balloon pump
14. Severe left ventricular dysfunction (LVEF) \< 30% by echocardiography
15. Calcified pericardium
16. Septal hypertrophy unacceptable for transapical procedure
17. Primary hypertrophic obstructive cardiomyopathy (HOCM)
18. Active infection, endocarditis or pyrexia
19. Active peptic ulcer or gastrointestinal (GI) bleeding within the past 3 months
20. Significant hepatic involvement (Child \> B)
21. Severe COPD requiring home oxygen
22. History of bleeding diathesis or coagulopathy
23. Hematologic disorder (WBC \< 3000mm3, Hb \< 9g/dL, platelet count \< 50000 cells/ mm3)
24. Chronic renal dysfunction with a serum creatinine level \> 2.5 mg/dL or renal failure requiring dialysis
25. Neurological disease severely affecting ambulation or daily functioning, including dementia
26. Another surgical or percutaneous procedure scheduled at the same time
27. Emergency procedure
28. Life expectancy \< 12 months due to non-cardiac co-morbid conditions
29. Known hypersensitivity/contraindication to any study medication, contrast media, or nitinol
30. Currently participating in an investigational drug or another device study

Primary outcomes:
measure: Freedom from all-cause mortality at 30 day Follow Up
timeFrame: 30-Day Follow-up
measure: Freedom from all-cause mortality at 12 months Follow Up
timeFrame: 12 months Follow-Up
Secondary outcomes:
measure: Rate of Major Adverse Valve-Related Events (MAVRE) at 30 days and at 12 month follow up related to the study device as defined as;
timeFrame: 30-Days and at 12 Months Follow-up
measure: Rate of Major Adverse Cardiac and Cerebrovascular-Related Events (MACCE) at 30 days and at 12 Month and defined as cardiovascular death, myocardial infarction and stroke.
timeFrame: 30-Day and 12-Month
measure: Functional Improvement from baseline
timeFrame: 30-Days and 12-Month Follow-up
measure: Procedural success
timeFrame: 24 hours Post-Procedure
measure: Device success at 30 Days and 12 Month follow-up as defined as adequate functioning of the study device as confirmed by angiography and/or echocardiography as assessed at a CoreLab.
timeFrame: 30-Day and 12-Month Follow-up
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik GmbH
city: Essen
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf Klinik für Herz-und Gefässchirurgie
city: Essen
country: Germany
facility: Universitätsklinikum Essen Westdeutsches Herzzentrum Essen
city: Karlsruhe
country: Germany
facility: Klinik für Herzchirurgie GmbH
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
Study officials:
affiliation: Kerckhoff Klinik
name: Thomas Walther, Professor
role: PRINCIPAL_INVESTIGATOR
References: