Safety and efficacy of the Symetis ACURATE neo/TF compared to the Edwards SAPIEN 3 bioprosthesis for transcatheter aortic valve implantation by transfemoral approach<br>

Phase 4

Completed

• Conditions: aortic valve regurgitation; heart valve disorder; 10046973

• Registration Number: NL-OMON48877
• Lead Sponsor: Inselspital and Bern University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary objective: to compare the performance of the Symetis ACURATE neo/TF to<br /><br>the Edwards SAPIEN 3 transcatheter aortic bioprosthesis with regard to early<br /><br>safety and clinical efficacy at 30 days </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives: to compare the Symetis ACURATE neo/TF with the Edwards<br /><br>SAPIEN 3 aortic bioprosthesis with regard to secondary clinical and<br /><br>echocardiographic endpoints at 30 days, 1 year and 3 years</p><br>