Clinical trial NCT03567278: Feasibility Trial on ACURATE™ Transapical Implantation in Patients With Severe Symptomatic Aortic Stenosis (2009-01)
Official title: Feasibility Trial on ACURATE™ Transapical Implantation in Patients With Severe Symptomatic Aortic Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Stenosis Symptomatic
Keywords: Severe Symptomatic Aortic Valve Stenosis
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2018-06-25
Enrollment: 40
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Medical Device Study
Primary purpose: TREATMENT

Brief summary: Feasibility Trial on the ACURATE TA™ transapical implantation in patients presenting severe symptomatic aortic stenosis to collect human feasibility data pertaining to the safety and performance of the device.

Detailed description: A single arm, prospective, multicenter, open trial up to 5 year follow-up with the SYMETIS ACURATE TA™ which is an aortic bioprosthesis for minimal invasive implantation via 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 the feasibility and performance of the implantation and the safety at 30-Day follow-up.

Eligibility criteria: Inclusion Criteria:

* Patients older than 75 years;
* Additive EuroSCORE \> 9 and/or STS \> 9%;
* Severe symptomatic AS assessed by echocardiography, documented by a derived mean gradient \> 40mmHg,and a native Aortic Valve Area (AVA) \< 0.8 cm² or Aortic Valve Area Index (AVAI) \< 0.6 cm²/m²;
* NYHA Functional Class \> II;
* Aortic annulus (AAn) diameters between and including 21 mm up to 27 mm (21mm ≤ AAn ≤27mm) by transoesophageal echocardiography;
* Sinotubular junction (STJ) higher than 1,1times the native aortic annulus diameter (AAn) \[STJ\>1.1xAAn\] AND STJ\<45mm by transoesophageal echocardiography;
* Patient understands the implications of participating in the study and provides signed informed consent

Exclusion Criteria:

* Congenital unicuspid or bicuspid aortic valve;
* Severe eccentricity of calcification;
* Severe mitral regurgitation (\> 2°);
* Pre-existing prosthetic heart valve in any position and /or prosthetic ring;
* Severe transapical access problem, non-reachable LV apex;
* Previous surgery of the LV using a patch, such as the Dor procedure;
* Presence of apical LV thrombus;
* Echocardiographic evidence of intracardiac mass, thrombus, or vegetation;
* Acute Myocardial Infarction (AMI) within 1 month prior to the procedure;
* PCI within 1 month prior to the procedure;
* Previous Transient Ischemic Accident (TIA) or stroke in the last 3 months;
* Untreated clinically significant CAD requiring revascularization;
* Hemodynamic instability: systolic pressure \<90mmHg without afterload reduction, shock, need for inotropic support or intra-aortic balloon pump;
* Severe left ventricular dysfunction with a LV Ejection Fraction (LVEF) \< 25% by echocardiography;
* Calcified pericardium;
* Septal hypertrophy;
* Primary Hypertrophic Obstructive Cardiomyopathy (HOCM);
* Active infection, endocarditis or pyrexia;
* Active peptic ulcer or Gastrointestinal (GI) bleeding within the past 3 months;
* Significant hepatic involvement (Child \> B);
* Major lung disease (FEV \< 0.8 or FEV1% \< 30% of normal);
* Pulmonary hypertension;
* History of bleeding diathesis or coagulopathy;
* Hematologic disorder (WBC\<3000mm3, Hb\<9g/dL, platelet count \<50000 cells/ mm3);
* Serum creatinine level greater than 3.0 mg/dL or chronic renal failure requiring dialysis;
* Neurological disease severely affecting ambulation or daily functioning, including dementia;
* Other procedure scheduled at the same time, whether surgery or percutaneous approach;
* Emergency procedure;
* Life expectancy \< 12 months due to non-cardiac co-morbid conditions;
* Known hypersensitivity/contraindication to any study medication, contrast media, or nitinol;
* Currently participating in an investigational drug or another device study

Primary outcomes:
measure: Safety endpoint
timeFrame: 30 days
Secondary outcomes:
measure: Performance endpoint
timeFrame: Up to 24-hours post-procedure
measure: Performance endpoint
timeFrame: Up to 24-hours post-procedure
measure: Mortality
timeFrame: 30 days, 60 days, 3 months, 6 months and 12 months
measure: MAVRE at follow-up
timeFrame: discharge or 7 days, 3 months, 6 months and 12 months
measure: MACCE or Major Adverse Cardiac and Cerebrovascular Event
timeFrame: 1 month, 3 months, 6 months and 12 months
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik GmbH
city: Essen
country: Germany
facility: Universitätsklinikum Essen Westdeutsches Herzzentrum Essen
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg Herz- und Gefäßchirurgie
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf Klinik für Herz-und Gefäßchirurgie
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
Study officials:
affiliation: Herzzentrum Leipzig GmbH
name: Friedrich Mohr, Professor
role: PRINCIPAL_INVESTIGATOR
References: