To further evaluate the safety, efficacy and device performance of the ACURATE neo2* aortic bioprosthesis and ACURATE neo2* transfemoral delivery system in 2000 consecutive patients with severe aortic stenosis according to VARC-3 criteria.
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
All-cause mortality up to 12 months follow-up.
Secondary outcome
- Clinical endpoints according to VARC-3 at the respective time points:
mortality, neurologic events, myocardial infarction, re-hospitalization,
bleeding and transfusions, vascular and access-related complications, cardiac
structural complications, other procedural or valve-related complications, new
conduction disturbance and arrhythmia, acute kidney injury, bioprosthetic valve
dysfunction, clinically significant valve thrombosis, and patient-reported
outcomes and health status (Kansas City Cardiomyopathy Questionnaire)
- Technical success at exit from procedure room (VARC-3)
- Device success at 30 days (VARC-3)
- Early safety at 30 days (VARC-3)
- Clinical efficacy at 12 months (VARC-3)
- Change of hemodynamic function (effective orifice area and mean
transprosthetic gradient) post-procedure at hospital discharge, 30 days and 12
months
- Moderate or severe haemodynamic valve deterioration after 12 months
- Moderate and severe prosthesis-patient mismatch at hospital discharge
- Total aortic regurgitation post-procedure at hospital discharge and 12 months
- Bioprosthetic valve failure at hospital discharge and at 12 months
Background summary
Over the last two decades, TAVI has become an essential treatment option for
patients with severe aortic valve stenosis. This technique treats aortic
stenosis by displacing and functionally replacing the native valve with a
bioprosthetic valve delivered on a catheter. The ACURATE neo bioprosthetic
aortic valve is one of several transcatheter heart valve (THV) designs
available for transfemoral TAVI. The key features of this self-expanding THV
are a supra-annular design and porcine pericardial leaflets. A further
characteristic is a topdown deployment as well as three stabilization arches
and an upper crown.
Study objective
To further evaluate the safety, efficacy and device performance of the ACURATE
neo2* aortic bioprosthesis and ACURATE neo2* transfemoral delivery system in
2000 consecutive patients with severe aortic stenosis according to VARC-3
criteria.
Study design
Single arm, multicenter, prospective, observational study with embedded
substudies.
Study burden and risks
There are no risks to subjects associated with participation in the study and
the burden is minimal for subjects when participating in the study.
Ritterstr. 26
Leipzig 04109
DE
Ritterstr. 26
Leipzig 04109
DE
Listed location countries
Age
Inclusion criteria
1. Planned transcatheter treatment of severe aortic stenosis with the ACURATE
neo2 aortic bioprosthesis and ACURATE neo2 transfemoral delivery system. 2. Age
>= 18 years of age. 3. Written informed consent by patient and/or legal
representative.
Exclusion criteria
1. Patient is unlikely to be able or willing to follow the investigator's
instructions during study
participation.
2. Patients temporally unable to provide written informed consent (e. g.
unconscious
emergency patients).
3. Patients placed in an institution by official or court order.
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 |
|---|---|
| Other | NCT05539573 |
| CCMO | NL83969.078.23 |