ACURATE neo2™ Post Market Clinical Follow up Study
- Conditions
- Aortic Valve CalcificationAortic Valve StenosisAortic Diseases
- Registration Number
- NCT04655248
- Lead Sponsor
- Boston Scientific Corporation
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 250
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.
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Assessments using 4D CT-scan 30 days 1 year * Assessment of leaflet mobility
* Assessment of hypoattenuated leaflet thickening (HALT)
* Assessment of leaflet thrombosisSafety endpoints adjudicated by an independent Clinical Events Committee all 5 years 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)
Additional Safety Endpoints all 5 years * 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 endocarditisEuroQoL Quality of Life questionnaire (EQ-5D-5L) Baseline, 30-day, 1-year Health status as evaluated by the EQ-5D-5L Quality Of Life questionnaire
Prosthetic Aortic Valve Performance as measured by transthoracic echocardiography (TTE) Discharge, 30 days, annually from year 1 to 5 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.New York Heart Association (NYHA) functional classification Baseline, Discharge, 30 days, annually from year 1 to 5 Classification of heart failure symptoms as evaluated by NYHA classification
Trial Locations
- Locations (19)
UMC Utrecht
🇳🇱Utrecht, Netherlands
Hospital Clinico de Santiago
🇪🇸Santiago De Compostela, Spain
St.-Johannes-Hospital
🇩🇪Dortmund, Germany
Aarhus Universitetshospital
🇩🇰Aarhus, Denmark
Universitätsklinik Regensburg
🇩🇪Regensburg, Germany
Azienda Ospedaliera Pisana
🇮🇹Pisa, Italy
Hospital Clinico Universitario Valladolid
🇪🇸Valladolid, Spain
Karolinska Universitetssjukhuset
🇸🇪Stockholm, Sweden
Liverpool Heart and Chest Hospital
🇬🇧Liverpool, United Kingdom
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom
San Raffaele Hospital
🇮🇹Milano, Italy
Odense University Hospital
🇩🇰Odense, Denmark
A.O.U Policlinico "G.Rodolico - San Marco"
🇮🇹Catania, CA, Italy
Rigshospitalet
🇩🇰Copenhagen, Denmark
Kerckhoff-Klinik GmbH Herz und Thorax Zentrum Abteilung Kardiologie/Kardiochirurgie
🇩🇪Bad Nauheim, Germany
HDZ Bad Oeynhausen
🇩🇪Bad Oeynhausen, Germany
Lund University, Cardiology department
🇸🇪Lund, Sweden
Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
Universitätsspital Zürich
🇨🇭Zürich, Switzerland