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Completed

NCT Number: NCT03003650

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

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Key information

Conditions

Symptomatic Aortic Stenosis

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 75 years of age and older
  • Logistic EuroSCORE ≥ 20%
  • 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
  • New York Heart Association (NYHA) Functional Class > II
  • Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by Trans-esophageal Echocardiography (TEE)
  • Patient not a surgical candidate due to significant co-morbid conditions unrelated to aortic stenosis
  • Patient willing to participate in the study and provide signed informed consent

Exclusion criteria

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

Treatment and study plan

ACURATE TF™

Device

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

Primary outcomes

  1. Freedom from all-cause mortality

    Time frame: 30-Day Follow-up

    Rate of all-cause mortality

Secondary outcomes

  1. Rate of MACCE (major cardiac and cerebrovascular event) related to the ACURATE TF™ Transfemoral Aortic Bioprosthesis and Delivery System.

    Time frame: 30-Days and 12 Months Follow-up

    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.

  2. Change in NYHA class over time

    Time frame: 30-Day and 12-Month

    Functional improvement from baseline NYHA classification at 30 day and at 12 month follow-up.

  3. Procedural success during device implantation

    Time frame: intraoperative

    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.

  4. Device success

    Time frame: 30-Day and 12-Month Follow-up

    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

Sponsors and collaborators

Lead sponsor

Symetis SA

Industry

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2017
First posted
Dec 28, 2016
Registry last updated
Nov 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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