Clinical trial NCT02986737: ACURATE Neo™ Aortic Bioprosthesis for Implantation Using the ACURATE TA™ LP Transapical Delivery System in Patients With Severe Aortic Stenosis
Official title: ACURATE Neo™ Aortic Bioprosthesis for Implantation Using the ACURATE TA™ LP 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: 2016-12-08
Enrollment: 15
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 trial
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Trial of ACURATE neo(TM) Aortic Bioprosthesis for Implantation using the ACURATE TA(TM) LP Transapical Delivery System in Patients with Severe Aortic Stenosis for evaluating the Safety and performance of the study device

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. Patient 75 years of age and older
2. Severe aortic stenosis defined as:

   Mean aortic gradient \> 40mmHg or o Peak jet velocity \> 4.0m/sor Aortic valve area of \< 1.0cm2
3. High risk candidate for conventional AVR defined as:

   STS score ≥ 10 or Multidisciplinary heart team (cardiologist and cardiac surgeon) consensus that patient is not a surgical candidate for conventional AVR due to significant co- morbid conditions unrelated to aortic stenosis
4. NYHA Functional Class \> II
5. Multidisciplinary heart team (cardiologist and cardiac surgeon) consensus that the transapical approach is the most suitable TAVI access route
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
2. Extreme eccentricity of calcification
3. Severe mitral regurgitation (\> Grade 2)
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 \< 30% by ECHO
13. Emergency procedure pre-implant including CAD requiring revascularization
14. Any percutaneous intervention, except for balloon valvuloplasty (BAV) within 1 month prior to implant procedure
15. Acute myocardial infarction within 1 month prior to implant procedure
16. Previous TIA or stroke within 3 months prior to implant procedure
17. Active gastrointestinal (GI) bleeding within 3 months prior to implant procedure
18. Scheduled surgical or percutaneous procedure to be performed prior to 30 day visit
19. History of bleeding diathesis or coagulopathy or refusal of blood transfusions
20. Systolic pressure \<80mmHg, cardiogenic shock, need for inotropic support or IABP
21. Primary hypertrophic obstructive cardiomyopathy (HOCM)
22. Active infection, endocarditis or pyrexia
23. Hepatic failure (\> Child B)
24. Chronic renal dysfunction with serum creatinine \> 2.5 mg/dL or renal dialysis
25. Refusal of surgery
26. Severe COPD requiring home oxygen
27. Neurological disease severely affecting ambulation, daily functioning, or dementia
28. Life expectancy \< 12 months due to non-cardiac co-morbid conditions
29. Contraindication to study medication, contrast media, or allergy to nitinol
30. Currently participating in an investigational drug or another device study

Primary outcomes:
measure: All cause mortality
timeFrame: 30 days
measure: Mean aortic gradient after device implantation
timeFrame: 7 days or Discharge
Secondary outcomes:
measure: rate of clinical endpoints VARC II
timeFrame: 30 days and month 12
measure: procedural success
timeFrame: procedure
measure: device success assessed according to composite VARC 2 criteria
timeFrame: 7 days, 30 days, 12 months
measure: functional improvement from Baseline as per NYHA Functional Classification
timeFrame: 30 days and 12 months follow up
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik
city: Hamburg
country: Germany
facility: Klinik für Herz-und Gefäßchirurgie
Study officials:
affiliation: Abteilung Herzchirurgie Kerckhoff-Klinik
name: Mirko Doss, Prof.Dr.Med
role: PRINCIPAL_INVESTIGATOR
References: