ACURATE neo2™ Post Market Clinical Follow up Study

NCT04655248 · tracked via the Priya Life Science Germany tracker

Sponsor

Boston Scientific Corporation

Phase

Observational

Started

2020-12-16

Last updated

2025-06-25

Condition(s) studied

Aortic Valve StenosisAortic Valve CalcificationAortic Diseases

Investigational drug(s) / intervention(s)

Transcatheter Aortic Valve Implantation/Replacement

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

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

Trial sites (19)

Facility	City	Region
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
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

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Other trials for the same condition

accuRate Evaluation of Benefit With Optimal Medical Treatment With or Without Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis Active, not recruiting

Correlation of FFR and iFR With Cardiac PET Perfusion in Patients With Severe Aortic Valve Stenosis Recruiting

Effect of Fetal Aortic Valvuloplasty on Outcomes Recruiting

The Prospective Segeberg TAVI Registry Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04655248 on ClinicalTrials.gov ↗ ← All trials in Germany