Primary objective: to compare the performance of the Symetis ACURATE neo/TF to the Edwards SAPIEN 3 transcatheter aortic bioprosthesis with regard to early safety and clinical efficacy at 30 days Secondary objectives: to compare the Symetis ACURATE…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary objective: to compare the performance of the Symetis ACURATE neo/TF to
the Edwards SAPIEN 3 transcatheter aortic bioprosthesis with regard to early
safety and clinical efficacy at 30 days
Secondary outcome
Secondary objectives: to compare the Symetis ACURATE neo/TF with the Edwards
SAPIEN 3 aortic bioprosthesis with regard to secondary clinical and
echocardiographic endpoints at 30 days, 1 year and 3 years
Background summary
Transcatheter aortic valve implantion (TAVI) is an established and valuable
treatment option for patients with severe symptomatic aortic stenosis and at
high risk for surgical aortic valve replacement (SAVR). The use of TAVI is
rapidly expanding worldwide and the indications for TAVI are widening into
lower risk populations in view of favorable outcomes among high and
intermediate risk patients. Many novel devices are currently developed or
established devices undergo design reiterations to address limitations, such as
vascular access complications, paravalvular regurgitation, and
atrio-ventricular conductance disturbances. However, device comparisons by use
of randomized trials are scarce in particular for newer generation
transcatheter valves.
The Symetis ACURATE neo/TF, a self-expandable transcatheter valve delivered via
transfemoral access, that gained CE mark approval in September 2014 after
showing favorable procedural and short term results. The SCOPE I trial will
compare its performance to the balloon-expandable Edwards SAPIEN 3, a widely
used and well-established transcatheter heart valve of the second generation,
in a randomized fashion.
Study objective
Primary objective: to compare the performance of the Symetis ACURATE neo/TF to
the Edwards SAPIEN 3 transcatheter aortic bioprosthesis with regard to early
safety and clinical efficacy at 30 days
Secondary objectives: to compare the Symetis ACURATE neo/TF with the Edwards
SAPIEN 3 aortic bioprosthesis with regard to secondary clinical and
echocardiographic endpoints at 30 days, 1 year and 3 years
Study design
Investigator-initiated and conducted, block randomized (1:1), parallel,
two-arm, multicenter, non-inferiority trial.
Intervention
Pre-procedural evaluation encompasses exclusion of obstructive coronary artery
disease by means of coronary angiography or non-invasive imaging techniques,
transthoracic echocardiography to assess for concomitant valvular disease as
well as right and left heart function and an ECG-gated contrast-enhanced
multislice computed tomography (CT) to assess features and dimensions of the
aortic valve, choose prosthesis size and determine the implantation plane.
The intervention will be performed under local anaesthesia and conscious
sedation whenever possible and with orotracheal intubation as clinically
indicated. The placement of a right-ventricular temporary pacemaker will be
routinely performed. The valves will be implanted according to standard
practice. Predilatation is mandatory for the Symetis ACURATE neo/TF,
predilatation for the Edwards SAPIEN 3 and postdilatation will be left at the
operator*s discretion. Closure devices will be applied for access site closure
according to local practice. After successful TAVI, dual antiplatelet therapy
for at least 3 months is recommend-ed followed by life-long single antiplatelet
therapy among patients with normal sinus rhythm. Among patients with atrial
fibrillation anticoagulation with Vit-K antagonists or NOACs will be installed.
Study burden and risks
The risk is negligible.
Bern University Hospital - INSELSPITAL .
Bern 3010
CH
Bern University Hospital - INSELSPITAL .
Bern 3010
CH
Listed location countries
Age
Inclusion criteria
- Age * 75 years
- Patient with severe aortic stenosis defined by an aortic valve area (AVA) <
1cm2 or AVA indexed to body surface area (BSA) of <0.6 cm2/m2, including
low-flow severe aortic stenosis defined
by stroke volume index (SVI) <35ml/m2, as assessed by integration of
echocardiographic and invasive measurements
- Subject is symptomatic (heart failure with New York Heart Association (NYHA)
Functional Class > I, angina or syncope)
- Patient is considered at increased risk for mortality if undergoing
conventional surgical aortic valve replacement or judged as not operable as
determined either
- by a Logistic EuroSCORE > 20 % or
- by a STS-PROM score > 10% or
- by the heart team consisting of at least one cardiologist and cardiac
surgeon based on the integration of individual clinical and anatomical factors
not captured by risk-scores, the patient*s age, frailty and life-expectancy
- The heart team agrees on eligibility of the patient for participation and
that TAVI by transfemoral access constitutes the most appropriate treatment
modality, from which the patient will likely
benefit most
- Aortic annulus dimensions suitable for both valve types (area range:
338-573mm2 AND perimeter range: 66-85mm) based on ECG-gated multislice computed
tomographic measurements.
Findings of TEE and conventional aortography should be integrated in the
anatomic assessment if available
- Arterial aorto-iliac-femoral axis suitable for transfemoral access with a
minimum access vessel diameter * 6 mm as assessed by multislice computed
tomographic angiography and/or
conventional angiography.
- Patient is able to give informed consent and provides consent in written or
oral form in attendance of a witness
- Patient understands the purpose, the potential risks as well as benefits of
the trial and is willing to participate in all parts of the follow-up.
Exclusion criteria
- Non-valvular aortic stenosis
- Congenital aortic stenosis or unicuspid or bicuspid aortic valve
- Non-calcific acquired aortic stenosis
- Anatomy not appropriate for transfemoral transcatheter aortic valve
implantation due to size of the aortic annulus or degree or eccentricity of
calcification of the native aortic valve or tortuosity of the aorta or
ilio-femoral arteries
- Emergency procedure including patients in cardiogenic shock (low cardiac
output, vasopressor dependence, mechanical hemodynamic support)
- Severely reduced left ventricular (LV) function (ejection fraction <20%)
- Pre-existing prosthetic heart valve in aortic position
- Presence of mitral valve prosthesis
- Concomitant planned procedure except for percutaneous coronary intervention
(PCI)
- Planned non-cardiac surgery within 30 days
- Stroke within 30 days of the procedure.
- Myocardial infarction within 30 days of the procedure (except
type 2)
- Evidence of intra-cardiac mass, thrombus or vegetation
- Severe coagulation conditions
- Inability to tolerate anticoagulation/antiplatelet therapy
- Active bacterial endocarditis or other active infections
- Hypertrophic cardiomyopathy with or without obstruction
- Contraindication to contrast media or allergy to nitinol
- Participation in another trial, which would lead to deviations in the
preparation or performance of the intervention or the post- implantation
management from this protocol.
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 | NCT03011346 |
| CCMO | NL62224.041.17 |