To collect clinical and device performance outcomes data with the ACURATE neo2* Transfemoral Aortic Valve System as used inroutine clinical practice for the treatment of severe calcific aortic stenosis.
ID
Source
Brief title
Condition
- Other condition
- Cardiac valve disorders
Synonym
Health condition
severe native aortic valve stenosis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Safety Endpoint: All-cause mortality at 30 days after the index implant
procedure.
Primary Imaging Endpoint: Hypoattenuated leaflet thickening (HALT) as measured
by 4D CT at 30 days
Secondary outcome
Additional measurements based on the Valve Academic Research Consortiuma (VARC)
endpoints and definitions will be collected
peri- and post-procedure, at pre-discharge, at 30 days, and annually 1 through
5 years after the implant procedure, unless otherwise
specified: see protocol ACURATE neo2 PMCF Study-Specific Protocol 92383173
Rev/Ver B - pages 7-9
Background summary
Severe aortic valve stenosis is the narrowing of one of the heart*s major
valve. This narrowing reduces the amount of blood that can get to the body.
Severe aortic valve stenosis is caused by calcification of the heart valve
leaflets (tissue that opens and closes in the heart valve ) so that the valve
cannot work properly. If left untreated, excessive strain put on the heart
muscle will eventually cause it to fail or lead to other serious complications.
ACURATE neo2 Aortic Valve System is intended to be used to treat this symptoms
and restore a normal functionality of your heart. The device received CE
marked in April 2020 and the objective of this study is to evaluate the safety
performance of ACURATE neo2 Aortic valve.
Study objective
To collect 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.
Study design
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 Ethics Committee 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. Subjects who are enrolled but not implanted with
an ACURATE neo2 valve in the aortic position will be followed for safety
through 30 days after the initial attempted index procedure but will not
undergo 4D CT imaging. Subjects who require a second transcatheter valve
(valve-in-valve) or conversion to surgery during the index procedure will be
followed for safety through 1 year but will not undergo 4D CT imaging.
Study burden and risks
The patient may or may not receive any benefit from participating in this
study. However, medical science and future subjects may benefit from your
participation. It is possible that the collection of information on the
effectiveness and safety of the device will allow early detection of unforeseen
problems.
Boston Scientific International SAS 2 Rue René Caudron, Bâtiment H
Voisins-le-Bretonneux 78960
FR
Boston Scientific International SAS 2 Rue René Caudron, Bâtiment H
Voisins-le-Bretonneux 78960
FR
Listed location countries
Age
Inclusion criteria
There are no specific inclusion criteria set for this post-market surveillance
study. A subject must sign an IEC/REB-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 the study; in these subjects the 30-day imaging will be performed
30 days after discontinuation of anticoagulation.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04655248 |
| CCMO | NL74565.078.20 |