Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04655248

ACURATE neo2™ Post Market Clinical Follow up Study

The ACURATE Neo2 PMCF is aimed at collecting clinical and device performance outcomes data with the ACURATE neo2™ Transfemoral Aortic Valve System as used in routine clinical practice for the treatment of severe calcific aortic stenosis.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Aortic Valve Stenosis Aortic Diseases Aortic Valve Calcification Aortic Valve Disease Aortic Valve, Calcification of Cardiovascular Diseases Heart Diseases Heart Valve Diseases Vascular Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus Universitetshospital, Aarhus, Denmark

Loading trial locations.

About this study

ACURATE neo2 PMCF is a prospective, open-label, single-arm, multicenter, observational post-market surveillance study. All subjects deemed treatable with the ACURATE neo2 valve will be approached to participate in the study.

A subject who provides an Informed Consent Form (ICF) approved by the Independent Ethics Committee (IEC) and signed by the subject or the subject's legally authorized representative is considered enrolled once an attempt is made to insert the commercially available ACURATE neo2 Transfemoral Delivery System. Approximately 200 subjects will be enrolled.

Follow-up will occur at pre-discharge, 30 days, 1 year, and then annually from 2 through 5 years post index procedure per standard of care. Visits are in-person through 1 year and in-person (preferred) or via telephone interview in years 2 through 5. All subjects will undergo 4D computed tomography (CT) imaging at 30 days and 1 year.

ACURATE neo2 PMCF Study Design Overview Abbreviations: CT=computed tomography; ICF=Informed Consent Form

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

There are no specific inclusion criteria set for this post-market surveillance study. A subject must sign an IEC-approved ICF and the ACURATE neo2 Transfemoral Aortic Valve System should be used according to the commercial IFU.

Exclusion criteria

EC1. Subject has a previous bioprosthesis in the aortic position.

EC2. Subject has eGFR <30 mL/min (chronic kidney disease stage IV or stage V).

EC3. Subject has atrial fibrillation that cannot be rate controlled to ventricular response rate < 60 bpm.

EC4. Subject is expected to undergo chronic anticoagulation therapy after the TAVI procedure

Note : Subjects treated with short-term anticoagulation post-procedure can be included; in these subjects the 30-day imaging will be performed 30 days after discontinuation of anticoagulation.

Treatment and study plan

Transcatheter Aortic Valve Implantation/Replacement

Device

The device is placed in patients heart at the level of aortic valve through a transfemoral access from femoral groin as indicated in device IFU

Primary outcomes

  1. Primary Safety Endpoint:

    Time frame: 30 days

    All-cause mortality after the index implant procedure

  2. Primary Imaging Endpoint:

    Time frame: 30 days

    Hypoattenuated leaflet thickening (HALT) as measured by 4D CT

Secondary outcomes

  1. Safety endpoints adjudicated by an independent Clinical Events Committee

    Time frame: all 5 years

    All-cause mortality (cardiovascular and non-cardiovascular) Stroke (disabling and non-disabling) Bleeding (life-threatening [or disabling] and major) Vascular complications (major) Hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV)

  2. Additional Safety Endpoints

    Time frame: all 5 years

    • Myocardial infarction (periprocedural [≤72 hours post index procedure] and spontaneous [>72 hours post index procedure])
    • Acute kidney injury (≤7 days post index procedure) based on the AKIN System Stage 3 (including renal replacement therapy) and Stage 2
    • Repeat procedure for valve-related dysfunction (surgical or interventional therapy)
    • New permanent pacemaker implantation resulting from new or worsened conduction disturbances
    • New onset of atrial fibrillation or atrial flutter
    • Coronary obstruction (≤3 days post index procedure)
    • Ventricular septal perforation (≤3 days post index procedure)
    • Annular rupture (≤3 days post index procedure)
    • Cardiac tamponade (≤3 days post index procedure)
    • Valve migration
    • Valve embolization
    • Ectopic valve deployment
    • Transcatheter aortic valve (TAV)-in-TAV deployment
    • Prosthetic aortic valve thrombosis
    • Prosthetic aortic valve endocarditis

  3. Prosthetic Aortic Valve Performance as measured by transthoracic echocardiography (TTE)

    Time frame: Discharge, 30 days, annually from year 1 to 5

    Effective orifice area (EOA), Mean and Peak aortic gradients, peak aortic velocity, and grade of aortic regurgitation/paravalvular leak (PVL).

    Center-reported TTE measures will also be collected annually at 2 through 5 years per local standard of care for TAVI.

  4. EuroQoL Quality of Life questionnaire (EQ-5D-5L)

    Time frame: Baseline, 30-day, 1-year

    Health status as evaluated by the EQ-5D-5L Quality Of Life questionnaire

  5. New York Heart Association (NYHA) functional classification

    Time frame: Baseline, Discharge, 30 days, annually from year 1 to 5

    Classification of heart failure symptoms as evaluated by NYHA classification

  6. Assessments using 4D CT-scan

    Time frame: 30 days 1 year

    • Assessment of leaflet mobility
    • Assessment of hypoattenuated leaflet thickening (HALT)
    • Assessment of leaflet thrombosis

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2026
First posted
Dec 7, 2020
Registry last updated
Jun 25, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.