ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis:CE-approval Cohort

First clinical experience on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation in Patients with Severe Aortic Stenosis to collect human data pertaining to the safety and performance of the device from three different cohorts

Study Overview

• Status: Completed
• Conditions: Symptomatic Aortic Stenosis
• Intervention / Treatment: Device: ACURATE TF™

Detailed Description

A prospective, multicenter, "CE-approval cohort" analysis with the Symetis ACURATE TF™ Transfemoral Aortic Bioprosthesis for minimal invasive implantation via transfemoral access to treat patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be associated with high risk, to evaluate the feasibility and performance of the implantation at 30-Days and at 1-Year Follow-up.

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, CEP 04012-909
    • Instituto Dante Pazzanese de Cardiologia
• Germany
  • Bad Nauheim, Germany, 61231
    • Kerckhoff Klinik GmbH
  • Bonn, Germany, 53105
    • Universitätsklinikum Bonn
  • Hamburg, Germany, 20246
    • Universitares Herzzentrum Hamburg
  • Köln, Germany, 50937
    • Herzzentrum Universitätsklinikum Köln
• Japan
  • Osaka, Japan
    • Osaka University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 73 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients 75 years of age and older
2. Logistic EuroSCORE ≥ 20%
3. Severe aortic stenosis characterized by mean aortic gradient > 40 mmHg or peak jet velocity > 4.0 m/s or aortic valve area of < 1.0 cm2
4. New York Heart Association (NYHA) Functional Class > II
5. Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by Trans-esophageal Echocardiography (TEE)
6. Patient not a surgical candidate due to significant co-morbid conditions unrelated to aortic stenosis
7. Patient willing to participate in the study and provide signed informed consent

Exclusion Criteria:

1. Unicuspid or bicuspid aortic valve
2. Extreme eccentricity of calcification
3. Severe mitral regurgitation ( >2+)
4. Pre-existing prosthetic heart valve in any position and / or prosthetic ring
5. Aortic or peripheral anatomy NOT appropriate for transfemoral implant
6. Thoracic (TAA) or abdominal (AAA) aortic aneurysm
7. Presence of endovascular stent graft for treatment of TAA or AAA
8. TEE is contraindicated
9. Left Ventricular Ejection Fraction (LVEF) < 30% by echocardiography (ECHO)
10. ECHO evidence of intracardiac mass, thrombus, or vegetation
11. Acute Myocardial Infarction (AMI) within 1 month prior to implant procedure
12. Percutaneous Coronary Intervention (PCI), except for balloon valvuloplasty (BAV) within 1 month prior to implant procedure
13. Previous Transien Ischemic Attack (TIA) or stroke within 3 months prior to implant procedure
14. Active ulcer or gastrointestinal (GI) bleeding within 3 months prior to implant procedure
15. Any scheduled surgical or percutaneous procedure to be performed prior to 30 day visit
16. History of bleeding diathesis or coagulopathy or refusal of blood transfusions
17. Systolic pressure <80 mmHg, cardiogenic shock, need for inotropic support or Intra-Aortic Balloon Pump (IABP)
18. Primary hypertrophic obstructive cardiomyopathy (HOCM)
19. Active infection, endocarditis or pyrexia
20. Hepatic failure
21. Chronic renal dysfunction with serum creatinine > 2.5 mg/dL or renal dialysis
22. Refusal of surgery
23. Severe Chronic Obstructive Pulmonary Disease (COPD) requiring home oxygen
24. Neurological disease severely affecting ambulation or daily functioning, or dementia
25. Life expectancy < 12 months due to non-cardiac co-morbid conditions
26. Known hypersensitivity/contraindication to study medication, contrast media, or nitinol
27. Currently participating in an investigational drug or another device study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Symetis ACURATE TF™; Patient implanted with ACURATE TF™Bioprosthesis.	Device: ACURATE TF™; ACURATE TF™Transfemoral Aortic Bioprosthesis is intended for subjects with severe symptomatic Aortic Stenosis and are considered high risk for surgical conventional Aortic Valve Replacement .; Other Names: ACURATE TF™Transfemoral Aortic Bioprosthesis and Delivery System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from all-cause mortality	Rate of all-cause mortality	30-Day Follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of MACCE (major cardiac and cerebrovascular event) related to the ACURATE TF™ Transfemoral Aortic Bioprosthesis and Delivery System.	Rate of major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months follow-up related to ACURATE TF™ Transfemoral Aortic Bioprosthesis and Delivery System and defined as all cause death, myocardial infarction, re-intervention and stroke.	30-Days and 12 Months Follow-up
Change in NYHA class over time	Functional improvement from baseline NYHA classification at 30 day and at 12 month follow-up.	30-Day and 12-Month
Procedural success during device implantation	Procedural Success defined as stable study device placement at intended site and adequate device functioning immediately post-implantation, confirmed by angiography and echocardiography and without intra-procedural mortality.	intraoperative
Device success	Device success is defined as adequate functioning of the study device as confirmed by angiography and/or echocardiography. The following data points will be analyzed for adequate functioning of the study device: Effective orifice area and index (EOA); Peak jet velocity; Transvalvular aortic gradient (mean); Paravalvular and intravalvular (central) leak; Aortic Insufficiency; Valve function and morphology	30-Day and 12-Month Follow-up

Collaborators and Investigators

• Sponsor: Symetis SA

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: December 2, 2016
• First Submitted That Met QC Criteria: December 21, 2016
• First Posted (Estimate): December 28, 2016

Study Record Updates

• Last Update Posted (Actual): November 27, 2018
• Last Update Submitted That Met QC Criteria: November 22, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Severe Symptomatic Aortic Valve Stenosis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: TF89