ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis (2011-03) (2011-03)

ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis

First-In-Man Study on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation in Patients with Severe Aortic Stenosis to collect human feasibility data pertaining to the safety and performance of the device.

Study Overview

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

Detailed Description

A single arm, prospective, multicenter, non-randomized, open trial, up to 5 Years follow-up 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.

• Study Type: Interventional
• Enrollment (Actual): 140
• 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
    • Universitäres Herzzentrum Hamburg
  • Köln, Germany, 50937
    • Herzzentrum Universitätsklinikum Koln

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 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 < 1.0 cm2
4. New York Heart Association (NYHA) Functional Class > II
5. Aortic annulus diameter from ≥ 21mm up to ≤ 27mm measured by 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. Trans-esophageal echocardiogram (TEE) is contraindicated
9. Left Ventricle 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 Transient 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 Obstruction 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: ACURATE TF™ Aortic Valve System; ACURATE TF™ Aortic Valve System is intended for subjects with severe symptomatic Aortic Stenosis and considered high risk for surgical conventional Aortic Valve Replacement .	Device: ACURATE TF™ Aortic Valve System; Transcatheter Aortic Valve Implantation

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-Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of MACCE (major cardiac and cerebrovascular event)	Rate of major cardiac and cerebrovascular event (MACCE) defined as cardiovascular death, myocardial infarction and stroke	30-Days and 12-Months

Collaborators and Investigators

• Sponsor: Symetis SA

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2012
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): March 30, 2022

Study Registration Dates

• First Submitted: November 21, 2018
• First Submitted That Met QC Criteria: November 22, 2018
• First Posted (Actual): November 26, 2018

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• 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: 2011-03 (Other Identifier: CCRRC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No