ACURATE neo2™ Post Market Clinical Follow up Study

Aortic Valve Stenosis Clinical Trial

Official title:

ACURATE neo2™ Post Market Clinical Follow up Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04655248
• Other study ID #: S2410
• Status: Active, not recruiting
• Start date: December 16, 2020
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2024
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: December 31, 2026
• Est. primary completion date: March 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Diseases
• Aortic Valve Calcification
• Aortic Valve Stenosis

Intervention

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

Country	Name	City	State
Denmark	Aarhus Universitetshospital	Aarhus
Denmark	Rigshospitalet	Copenhagen
Denmark	Odense University Hospital	Odense
Germany	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
Italy	A.O.U Policlinico "G.Rodolico - San Marco"	Catania	CA
Italy	San Raffaele Hospital	Milano
Italy	Azienda Ospedaliera Pisana	Pisa
Netherlands	Erasmus Medical Center	Rotterdam
Netherlands	UMC Utrecht	Utrecht
Spain	Hospital Clinico de Santiago	Santiago De Compostela
Spain	Hospital Clinico Universitario Valladolid	Valladolid
Sweden	Lund University, Cardiology department	Lund
Sweden	Karolinska Universitetssjukhuset	Stockholm
Switzerland	Universitätsspital Zürich	Zürich
United Kingdom	Liverpool Heart and Chest Hospital	Liverpool
United Kingdom	John Radcliffe Hospital	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Denmark,  Germany,  Italy,  Netherlands,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety Endpoint:	All-cause mortality after the index implant procedure	30 days
Primary	Primary Imaging Endpoint:	Hypoattenuated leaflet thickening (HALT) as measured by 4D CT	30 days
Secondary	Safety endpoints adjudicated by an independent Clinical Events Committee	All-cause mortality (cardiovascular and non-cardiovascular) Stroke (disabling and non-disabling) Bleeding (life-threatening [or disabling] and major) Vascular complications (major) Hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV)	all 5 years
Secondary	Additional Safety Endpoints	Myocardial infarction (periprocedural [=72 hours post index procedure] and spontaneous [>72 hours post index procedure]); Acute kidney injury (=7 days post index procedure) based on the AKIN System Stage 3 (including renal replacement therapy) and Stage 2; Repeat procedure for valve-related dysfunction (surgical or interventional therapy); New permanent pacemaker implantation resulting from new or worsened conduction disturbances; New onset of atrial fibrillation or atrial flutter; Coronary obstruction (=3 days post index procedure); Ventricular septal perforation (=3 days post index procedure); Annular rupture (=3 days post index procedure); Cardiac tamponade (=3 days post index procedure); Valve migration; Valve embolization; Ectopic valve deployment; Transcatheter aortic valve (TAV)-in-TAV deployment; Prosthetic aortic valve thrombosis; Prosthetic aortic valve endocarditis	all 5 years
Secondary	Prosthetic Aortic Valve Performance as measured by transthoracic echocardiography (TTE)	Effective orifice area (EOA), Mean and Peak aortic gradients, peak aortic velocity, and grade of aortic regurgitation/paravalvular leak (PVL).; Center-reported TTE measures will also be collected annually at 2 through 5 years per local standard of care for TAVI.	Discharge, 30 days, annually from year 1 to 5
Secondary	EuroQoL Quality of Life questionnaire (EQ-5D-5L)	Health status as evaluated by the EQ-5D-5L Quality Of Life questionnaire	Baseline, 30-day, 1-year
Secondary	New York Heart Association (NYHA) functional classification	Classification of heart failure symptoms as evaluated by NYHA classification	Baseline, Discharge, 30 days, annually from year 1 to 5
Secondary	Assessments using 4D CT-scan	Assessment of leaflet mobility; Assessment of hypoattenuated leaflet thickening (HALT); Assessment of leaflet thrombosis	30 days 1 year