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ACTIVE NOT RECRUITING
NCT04655248

ACURATE neo2™ Post Market Clinical Follow up Study

Sponsor: Boston Scientific Corporation

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

250

Start Date

2020-12-16

Completion Date

2026-12-31

Last Updated

2025-06-25

Healthy Volunteers

No

Interventions

DEVICE

Transcatheter Aortic Valve Implantation/Replacement

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

Locations (19)

Aarhus Universitetshospital

Aarhus, Denmark

Rigshospitalet

Copenhagen, Denmark

Odense University Hospital

Odense, Denmark

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

Bad Nauheim, Germany

HDZ Bad Oeynhausen

Bad Oeynhausen, Germany

St.-Johannes-Hospital

Dortmund, Germany

Universitätsklinik Regensburg

Regensburg, Germany

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

Catania, CA, Italy

San Raffaele Hospital

Milan, Italy

Azienda Ospedaliera Pisana

Pisa, Italy

Erasmus Medical Center

Rotterdam, Netherlands

UMC Utrecht

Utrecht, Netherlands

Hospital Clinico de Santiago

Santiago de Compostela, Spain

Hospital Clinico Universitario Valladolid

Valladolid, Spain

Lund University, Cardiology department

Lund, Sweden

Karolinska Universitetssjukhuset

Stockholm, Sweden

Universitätsspital Zürich

Zurich, Switzerland

Liverpool Heart and Chest Hospital

Liverpool, United Kingdom

John Radcliffe Hospital

Oxford, United Kingdom