ACURATE neo2™ Post Market Clinical Follow up Study

NCT04655248 | Active Not Recruiting

• 1 other identifier: S2410
• Study Type: observational
• Target: 250
• Locations: 8 countries
• Sites: 19

Brief Summary

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.

Conditions

Aortic Valve Stenosis; Aortic Valve Calcification; Aortic Diseases

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Safety endpoints adjudicated by an independent Clinical Events Committee

  all 5 years

• Additional Safety Endpoints

  all 5 years

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

  Discharge, 30 days, annually from year 1 to 5

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

  Baseline, 30-day, 1-year

• New York Heart Association (NYHA) functional classification

  Baseline, Discharge, 30 days, annually from year 1 to 5

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (19)

Aarhus Universitetshospital

Aarhus, Denmark

Location

Rigshospitalet

Copenhagen, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

Kerckhoff-Klinik GmbH Herz und Thorax Zentrum Abteilung Kardiologie/Kardiochirurgie

Bad Nauheim, Germany

Location

HDZ Bad Oeynhausen

Bad Oeynhausen, Germany

Location

St.-Johannes-Hospital

Dortmund, Germany

Location

Universitätsklinik Regensburg

Regensburg, Germany

Location

A.O.U Policlinico "G.Rodolico - San Marco"

Catania, CA, 95123, Italy

Location

San Raffaele Hospital

Milan, Italy

Location

Azienda Ospedaliera Pisana

Pisa, Italy

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

UMC Utrecht

Utrecht, Netherlands

Location

Hospital Clinico de Santiago

Santiago de Compostela, Spain

Location

Hospital Clinico Universitario Valladolid

Valladolid, 47005, Spain

Location

Lund University, Cardiology department

Lund, Sweden

Location

Karolinska Universitetssjukhuset

Stockholm, Sweden

Location

Universitätsspital Zürich

Zurich, Switzerland

Location

Liverpool Heart and Chest Hospital

Liverpool, United Kingdom

Location

John Radcliffe Hospital

Oxford, United Kingdom

Location

Related Publications (1)

• Kim WK, Mollmann H, Montorfano M, Ellert-Gregersen J, Rudolph TK, Van Mieghem NM, Hilker M, Amat-Santos I, Terkelsen CJ, Petronio AS, Stella P, Gotberg M, Ruck A, Kasel AM, Trillo R, Appleby C, Barbanti M, Blanke P, Asch FM, Modolo R, Allocco DJ, Tamburino C. Outcomes and performance of the ACURATE neo2 transcatheter heart valve in clinical practice: one-yearresults of the ACURATE neo2 PMCF Study. EuroIntervention. 2024 Jan 1;20(1):85-94. doi: 10.4244/EIJ-D-23-00823.

  PMID: 37982152 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve, Calcification of; Aortic Diseases

Interventions

Transcatheter Aortic Valve Replacement; Replantation

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Vascular Diseases

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures; Transplantation

Study Officials

• Won-Keun Kim, MD

  Kerckhoff Klinik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 7, 2020
• Study Start: December 16, 2020
• Primary Completion: March 9, 2022
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

SE (2); GB (2); DE (4); NL (2); ES (2); CH (1); IT (3); DK (3)