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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Valve Stenosis; Aortic Diseases; Aortic Valve Calcification
• Intervention / Treatment: Device: Transcatheter Aortic Valve Implantation/Replacement

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark
    • Aarhus Universitetshospital
  • Copenhagen, Denmark
    • Rigshospitalet
  • Odense, Denmark
    • Odense University Hospital
• Germany
  • Bad Nauheim, Germany
    • Kerckhoff-Klinik GmbH Herz und Thorax Zentrum Abteilung Kardiologie/Kardiochirurgie
  • Bad Oeynhausen, Germany
    • HDZ Bad Oeynhausen
  • Dortmund, Germany
    • St.-Johannes-Hospital
  • Regensburg, Germany
    • Universitätsklinik Regensburg
• Italy
  • Milano, Italy
    • San Raffaele Hospital
  • Pisa, Italy
    • Azienda Ospedaliera Pisana
  • CA
    • Catania, CA, Italy, 95123
      • A.O.U Policlinico "G.Rodolico - San Marco"
• Netherlands
  • Rotterdam, Netherlands
    • Erasmus Medical Center
  • Utrecht, Netherlands
    • UMC Utrecht
• Spain
  • Santiago De Compostela, Spain
    • Hospital Clínico de Santiago
  • Valladolid, Spain, 47005
    • Hospital Clínico Universitario Valladolid
• Sweden
  • Lund, Sweden
    • Lund University, Cardiology department
  • Stockholm, Sweden
    • Karolinska Universitetssjukhuset
• Switzerland
  • Zürich, Switzerland
    • Universitätsspital Zürich
• United Kingdom
  • Liverpool, United Kingdom
    • Liverpool Heart and Chest Hospital
  • Oxford, United Kingdom
    • John Radcliffe Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic heart disease due to severe native calcific aortic stenosis

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Endpoint:	All-cause mortality after the index implant procedure	30 days
Primary Imaging Endpoint:	Hypoattenuated leaflet thickening (HALT) as measured by 4D CT	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety endpoints adjudicated by an independent Clinical Events Committee	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)	all 5 years
Additional Safety Endpoints	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	all 5 years
Prosthetic Aortic Valve Performance as measured by transthoracic echocardiography (TTE)	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.	Discharge, 30 days, annually from year 1 to 5
EuroQoL Quality of Life questionnaire (EQ-5D-5L)	Health status as evaluated by the EQ-5D-5L Quality Of Life questionnaire	Baseline, 30-day, 1-year
New York Heart Association (NYHA) functional classification	Classification of heart failure symptoms as evaluated by NYHA classification	Baseline, Discharge, 30 days, annually from year 1 to 5
Assessments using 4D CT-scan	Assessment of leaflet mobility; Assessment of hypoattenuated leaflet thickening (HALT); Assessment of leaflet thrombosis	30 days 1 year

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Won-Keun Kim, MD, Kerckhoff Klinik

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2020
• Primary Completion (Actual): March 9, 2022
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 30, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (Actual): December 7, 2020

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 15, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Diseases
• Other Study ID Numbers: S2410

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy. (http://www.bostonscientific.com/en-US/data-sharing-requests.html)

Drug and device information, study documents

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