Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
250 participants
OBSERVATIONAL
2020-12-16
2026-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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
Eligibility Criteria
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Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Won-Keun Kim, MD
Role: PRINCIPAL_INVESTIGATOR
Kerckhoff Klinik
Locations
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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
Countries
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References
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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.
Other Identifiers
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S2410
Identifier Type: -
Identifier Source: org_study_id
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