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Completed

NCT Number: NCT03143673

ACURATE™ Transapical Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis (2010-01)

The purpose of this study is to evaluate safety of the study device and study device performance in patients presenting with severe aortic stenosis who are considered to be high risk for open surgical repair.

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Key information

Conditions

Aortic Symptomatic Stenosis

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kerckhoff Klinik GmbH, Bad Nauheim, Germany

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About this study

A single arm, prospective, multicenter, non-randomized, and open trial, up to 5 years follow-up with the Symetis ACURATE TA™ which is an aortic bioprosthesis for minimal invasive implantation vie transapical access to treat patients with severe symptomatic aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be associated with high surgical risk for evaluating safety and performance of the implantation and safety at 30-D follow-up.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients at least 75 years of age
  • Additive EuroSCORE > 9
  • Severe AS assessed by echocardiography and documented by a mean gradient > 40mmHg and a native Aortic Valve Area (AVA) < 0.8 cm² or Aortic Valve Area Index (AVAI) < 0.6 cm²/m²
  • NYHA Functional Class > II
  • Aortic annulus (AAn) diameters between and including 21 mm up to 27 mm (21mm ≤ AAn ≤27mm) by transoesophageal echocardiography (TEE)
  • Patient understands the implications of participating in the study and provides signed informed consent

Exclusion criteria

  • Congenital unicuspid or bicuspid aortic valve
  • Severe eccentricity of calcification
  • Severe mitral regurgitation (> 2°)
  • Pre-existing prosthetic heart valve in any position and / or prosthetic ring
  • Severe transapical access problem, non-reachable LV apex
  • Previous surgery of the LV using a patch, such as the Dor procedure
  • Presence of apical LV thrombus
  • Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
  • Acute myocardial infarction (AMI) within 1 month prior to the procedure
  • PCI within 1 month prior to the procedure
  • Previous transient ischemic attack (TIA) or stroke in the last 3 months
  • Untreated clinically significant coronary artery disease (CAD) requiring revascularization
  • Hemodynamic instability: systolic pressure <90mmHg without afterload reduction, shock, need for inotropic support or intra-aortic balloon pump
  • Severe left ventricular dysfunction (LVEF) < 30% by echocardiography
  • Calcified pericardium
  • Septal hypertrophy unacceptable for transapical procedure
  • Primary hypertrophic obstructive cardiomyopathy (HOCM)
  • Active infection, endocarditis or pyrexia
  • Active peptic ulcer or gastrointestinal (GI) bleeding within the past 3 months
  • Significant hepatic involvement (Child > B)
  • Severe COPD requiring home oxygen
  • History of bleeding diathesis or coagulopathy
  • Hematologic disorder (WBC < 3000mm3, Hb < 9g/dL, platelet count < 50000 cells/ mm3)
  • Chronic renal dysfunction with a serum creatinine level > 2.5 mg/dL or renal failure requiring dialysis
  • Neurological disease severely affecting ambulation or daily functioning, including dementia
  • Another surgical or percutaneous procedure scheduled at the same time
  • Emergency procedure
  • Life expectancy < 12 months due to non-cardiac co-morbid conditions
  • Known hypersensitivity/contraindication to any study medication, contrast media, or nitinol
  • Currently participating in an investigational drug or another device study

Treatment and study plan

ACURATE TA™

Device

ACURATE TA™ Transapical Aortic Bioprosthesis is intended for subjects with severe symptomatic Aortic Stenosis and are considered high risk for surgical conventional Aortic Valve Replacement Surgery.

Other names: ACURATE TA™ Transapical Aortic Bioprosthesis and Delivery System

Primary outcomes

  1. Freedom from all-cause mortality at 30 day Follow Up

    Time frame: 30-Day Follow-up

    The primary study objective is to evaluate the safety of the ACURATE™ Transapical Aortic Bioprosthesis at 30 days post-procedure in patients presenting with severe aortic valve stenosis at high risk for conventional AVR surgery.

  2. Freedom from all-cause mortality at 12 months Follow Up

    Time frame: 12 months Follow-Up

    The primary study objective is to evaluate the safety of the ACURATE™ Transapical Aortic Bioprosthesis at 12 months post-procedure in patients presenting with severe aortic valve stenosis at high risk for conventional AVR surgery.

Secondary outcomes

  1. Rate of Major Adverse Valve-Related Events (MAVRE) at 30 days and at 12 month follow up related to the study device as defined as;

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

    2.1 Structural valve deterioration

    2.2 Non-structural dysfunction of the implanted study device

    2.3 Valve thrombosis, embolism, bleeding event

    2.4 Operated valve endocarditis

    2.5 Re-intervention on the implanted device

    2.6 Valve-related mortality

    2.7 Need for new permanent pacemaker or defibrillator within 14 days

  2. Rate of Major Adverse Cardiac and Cerebrovascular-Related Events (MACCE) at 30 days and at 12 Month and defined as cardiovascular death, myocardial infarction and stroke.

    Time frame: 30-Day and 12-Month

    Defined as cardiovascular death, myocardial infarction and stroke

  3. Functional Improvement from baseline

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

    per NYHA functional classification

  4. Procedural success

    Time frame: 24 hours Post-Procedure

    defined as stable study device placement at intended site and adequate device functioning immediately post-implantation, confirmed by angiography and echocardiography as assessed at a Core Lab and without intraprocedural mortality.

  5. Device success at 30 Days and 12 Month follow-up as defined as adequate functioning of the study device as confirmed by angiography and/or echocardiography as assessed at a CoreLab.

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

    Device success at 30 Days and 12 Month follow-up as defined as adequate functioning of the study device as confirmed by angiography and/or echocardiography as assessed at a CoreLab. The following datapoints will be analyzed:

    6.1 Effective orifice area and index (EOA/EOAI)

    6.2 Transvalvular Gradients (Peak and mean)

    6.3 Paravalvular and intravalvular (Central) leaks

    6.4 Aortic Insufficiency

    6.5 LV function and hemodynamics

    6.6 Valve function and morphology

Sponsors and collaborators

Lead sponsor

Symetis SA

Industry

Registry information

Official study title

ACURATE™ Transapical Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis

Acronym: TA-PILOT

Important dates

Study start
2011
Primary completion
2011
Study completion
2015
First posted
May 8, 2017
Registry last updated
Jul 27, 2023

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.