Clinical trial NCT04655248: ACURATE neo2™ Post Market Clinical Follow up Study
Official title: ACURATE neo2™ Post Market Clinical Follow up Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Aortic Valve Stenosis
Aortic Valve Calcification
Aortic Diseases
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2020-12-07
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic heart disease due to severe native calcific aortic stenosis

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.

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

Eligibility criteria: 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 outcomes:
measure: Primary Safety Endpoint:
timeFrame: 30 days
measure: Primary Imaging Endpoint:
timeFrame: 30 days
Secondary outcomes:
measure: Safety endpoints adjudicated by an independent Clinical Events Committee
timeFrame: all 5 years
measure: Additional Safety Endpoints
timeFrame: all 5 years
measure: Prosthetic Aortic Valve Performance as measured by transthoracic echocardiography (TTE)
timeFrame: Discharge, 30 days, annually from year 1 to 5
measure: EuroQoL Quality of Life questionnaire (EQ-5D-5L)
timeFrame: Baseline, 30-day, 1-year
measure: New York Heart Association (NYHA) functional classification
timeFrame: Baseline, Discharge, 30 days, annually from year 1 to 5
measure: Assessments using 4D CT-scan
timeFrame: 30 days 1 year
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Odense
country: Denmark
facility: Odense University Hospital
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik GmbH Herz und Thorax Zentrum Abteilung Kardiologie/Kardiochirurgie
city: Bad Oeynhausen
country: Germany
facility: HDZ Bad Oeynhausen
city: Dortmund
country: Germany
facility: St.-Johannes-Hospital
city: Regensburg
country: Germany
facility: Universitätsklinik Regensburg
city: Catania
country: Italy
facility: A.O.U Policlinico "G.Rodolico - San Marco"
state: CA
city: Milano
country: Italy
facility: San Raffaele Hospital
city: Pisa
country: Italy
facility: Azienda Ospedaliera Pisana
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Santiago De Compostela
country: Spain
facility: Hospital Clinico de Santiago
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario Valladolid
city: Lund
country: Sweden
facility: Lund University, Cardiology department
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: Kerckhoff Klinik
name: Won-Keun Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: