Clinical trial NCT02950428: ACURATE Neo™ TA Delivery System in Patient With Severe Aortic Stenosis
Official title: ACURATE Neo™ Aortic Bioprosthesis for Implantation Using the ACURATE Neo™ TA Transapical Delivery System in Patients With Severe Aortic Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Stenosis
Keywords: TAVI
Aortic Stenosis
transcatether Aortic Valve Implantation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2016-11-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this investigation is to collect data pertaining to the safety and performance of the ACURATE neo (TM) Aortic Bioprosthesis as implanted with the ACURATE neo (TM) TA Transapical Delivery System. This device is intended for treatment of subjects with severe aortic stenosis (AS) who have high risk for conventional aortic valve replacement (AVR) surgery. The ACURATE neo (TM) Aortic Bioprosthesis is intended for use via minimally-invasive transapical implantation in a well-defined population.

Detailed description: This is a single arm, prospective, multicenter non randomised and open trial of the treatment of patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be high risk. All patients will be followed up to 5 years after the intervention.

The primary objective is to evaluate the safety and performance of the study device in patients presenting with severe aortic stenosis considered to be high risk for surgery Secondary objective is to evaluate adverse events and study device performance.

Eligibility criteria: Inclusion Criteria:

1. Subject must be at least 18 years old
2. Severe aortic stenosis defined as:

   * Mean aortic gradient \> 40 mmHg or
   * Peak jet velocity \> 4.0 m/s or
   * Aortic valve area of \< 0.8 cm2
3. High risk patient determined by a multidisciplinary heart team consensus (cardiologist and cardiac surgeon) that patient is not a surgical candidate for conventional AVR due to risk factors such as STS Score (8% or higher) or other co-morbid conditions unrelated to aortic stenosis such as severe chronic obstructive pulmonary disease (COPD), chest deformities and irradiated mediastinum
4. NYHA Functional Class \> II
5. Multidisciplinary heart team (cardiologist and cardiac surgeon) consensus that the transapical approach is the most suitable access route for TAVI due to the presence of the following anatomic conditions:

   * porcelain aorta or
   * severely calcified or highly tortuous peripheral vasculature not appropriate for transfemoral transcatheter aortic valve implantation or
   * vessels too small for retrograde approach or
   * other anatomical conditions making transapical approach more suitable
6. Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by CT or TEE
7. Patient willing to participate in the study and provides signed informed consent

Exclusion Criteria:

1. Congenital unicuspid or bicuspid aortic valve or non-calcified
2. Extreme eccentricity of calcification
3. Severe mitral regurgitation (\> Grade 3)
4. Pre-existing prosthetic heart valve in any position and / or prosthetic ring
5. LV apex is not accessible via transapical access due to severe chest deformity
6. Previous surgery of the LV using a patch, such as the Dor procedure
7. Presence of apical LV thrombus
8. Calcified pericardium
9. Septal hypertrophy unacceptable for transapical procedure
10. Transesophageal echocardiogram (TEE) is contraindicated
11. ECHO evidence of intracardiac mass, thrombus, or vegetation
12. LVEF \< 20% by ECHO
13. Need for emergency intervention for any reason within 30 Days of scheduled procedure
14. Any percutaneous intervention, except for balloon valvuloplasty (BAV) within 1 month prior to implant procedure
15. Untreated clinically significant coronary artery disease requiring revascularization within 30 days before or after the study procedure
16. Acute myocardial infarction within 1 month prior to implant procedure
17. Previous TIA or stroke within 6 months prior to implant procedure
18. Active gastrointestinal (GI) bleeding within 3 months prior to implant procedure
19. Scheduled surgical or percutaneous procedure to be performed prior to 30 day visit
20. History of bleeding diathesis, coagulopathy, refusal of blood transfusions or severe anemia (Hb\<8 g/dL)
21. Systolic pressure \<80mmHg, cardiogenic shock, need for inotropic support or IABP
22. Primary hypertrophic obstructive cardiomyopathy (HOCM)
23. Active infection or endocarditis
24. Hepatic failure (\> Child B)
25. Chronic renal dysfunction with serum creatinine \> 3.0 mg/dL or renal dialysis
26. Neurological disease severely affecting ambulation, daily functioning, or dementia
27. Life expectancy \< 12 months due to non-cardiac co-morbid conditions
28. Intolerance to aspirin, clopidogrel, contrast media, or porcine tissue and allergy to nickel
29. Pregnant or breast-feeding women
30. For other severe illnesses of the patient (e.g. active carcinoma), the investigator shall decide on an individual basis whether the patient is not to be included in the study
31. Currently participating in an investigational drug or another device study

Primary outcomes:
measure: Primary Safety: freedom from all-cause mortality
timeFrame: 6 months post procedure
measure: Primary Device Performance:Procedure success in absence of MACCE
timeFrame: 30 days post procedure
Secondary outcomes:
measure: Rate of clinical endpoints according to the Valve Academic Research Consortium (VARC 2) guidelines
timeFrame: 30 Days and month 12
measure: Incidence of all cause mortality at 30 Days and 12 Months
timeFrame: 30 days and 12 months
measure: Freedom from MACCE at 30 Days, 6 Months and 12 Months
timeFrame: 30 Days, 6 Months and 12 Months
measure: Number of patients who have a Procedural success defined by a combination of criteria
timeFrame: procedure
measure: Rate of device success
timeFrame: 7 days/ Discharge, 30 Days, 6 Months and at 12 Months
measure: NYHA Functional Classification improvement
timeFrame: 30 Days, 6 Month and at 12 Months
measure: Echocardiographic assessment of valve performance (at 7 Days or Discharge, 30 Days, 6 Months, 12 Months) using a combination of measures
timeFrame: 7 Days or Discharge, 30 Days, 6 Months, 12 Months
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik
city: Bad Oeynhausen
country: Germany
facility: Krankenhausbetriebsgesellschaft
city: Berlin
country: Germany
facility: Deutsched Herzzentrum Berlin
city: Halle (Saale)
country: Germany
facility: Martin Luther University Halle Winttenberg
city: Hamburg
country: Germany
facility: Universitätklinikum Hamburg Eppendorf
city: Leipzig
country: Germany
facility: Herzentrum Leipzig GmbH
city: Regensburg
country: Germany
facility: University Hospital Regensburg
Study officials:
affiliation: Abteilung Herzchirurgie Kerckhoff-Klinik
name: Markus Pr Schönburg, Prof.Dr.Med
role: PRINCIPAL_INVESTIGATOR
References:
citation: Conradi L, Hilker M, Kempfert J, Borgermann J, Treede H, Holzhey DM, Schrofel H, Kim WK, Schaefer U, Walther T. Prospective multicentre evaluation of a novel, low-profile transapical delivery system for self-expandable transcatheter aortic valve implantation: 6-month outcomes. Eur J Cardiothorac Surg. 2018 Oct 1;54(4):762-767. doi: 10.1093/ejcts/ezy097.