Evaluating the ACURATE Neo 2 Valve for Severe Aortic Valve Stenosis

The Use of ACURATE Neo 2 Valve in Patients With Symptomatic Aortic Valve Stenosis

This study is testing the ACURATE Neo2 heart valve to see if it helps people with severe aortic stenosis feel better after treatment.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Sex: All
• Sponsor: Ceric Sàrl (Industry-sponsored)
• Locations: 7 sites (Aswan and 6 other locations)
• Trial ID: NCT05847751 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the effectiveness of the ACURATE Neo2 valve in patients with severe symptomatic aortic stenosis in the Middle East. Patients requiring intervention for severe aortic stenosis will be evaluated by a Heart Team, which includes interventional cardiologists and cardiovascular surgeons, to determine the best treatment strategy. Eligible patients will receive the ACURATE Neo2 bioprosthesis and will be monitored for clinical outcomes at discharge and 30 days post-procedure. The study focuses on capturing safety and efficacy data to inform future treatment protocols.

Who should consider this trial

Good fit: Ideal candidates are patients with severe symptomatic aortic stenosis who are at high or intermediate risk for surgery and are eligible for transcatheter aortic valve replacement.

Not a fit: Patients with mild aortic stenosis or those who do not meet the eligibility criteria for TAVR may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment outcomes for patients with severe aortic stenosis by providing a new effective valve option.

How similar studies have performed: Other studies have shown success with similar transcatheter valve approaches, indicating potential for positive outcomes with the ACURATE Neo2 valve.

Eligibility criteria

Inclusion Criteria:

* Subject will be included if all of the following criteria are met:

  * 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 symptoms with New York Heart Association (NYHA) Functional Class \> I, angina or syncope)
  * Patient is considered at high (STS-PROM (Society of Thoracic Surgeons-Predicted Risk of Mortality) score \>8) or intermediate (STS-PROM score \>4) risk by the Heart Team.
  * The heart team agrees on eligibility of the patient for participation and that TAVR (Transcatheter aortic valve replacement) (TAVR) by transfemoral access constitutes the most appropriate treatment modality, from which the patient will likely benefit most
  * Aortic annulus dimensions suitable (area range: 338-573 mm2 AND perimeter range: 66-85 mm) based on ECG-gated multislice computed tomographic measurements. Findings of transesophageal echocardiography (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
  * Written informed consent of the patient or her/his legal representative
  * 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:

* Subject will not be included if any one of the following conditions exists:

  * 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/anti-platelet therapy
  * Active bacterial endocarditis or other active infections
  * Hypertrophic cardiomyopathy
  * 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

Where this trial is running

Aswan and 6 other locations

• Magdy Yacoub heart center — Aswan, Egypt (Not_yet_recruiting)
• Ain shams Specialized hospital — Cairo, Egypt (Not_yet_recruiting)
• Badr hospital — Cairo, Egypt (Not_yet_recruiting)
• American University of Beirut — Beirut, Lebanon (Recruiting)
• King Fahad Armed Forces Hospital — Jeddah, Saudi Arabia (Recruiting)
• King Fahad National Guard Hospital — Riyadh, Saudi Arabia (Recruiting)
• National Guard Hospital - King Abdulaziz Medical City — Riyadh, Saudi Arabia (Not_yet_recruiting)

Study contacts

• Principal investigator: Mohamed BALGHITH, MD — King Fahad National Guard Hospital
• Study coordinator: Christophe LE ROUX, MSc

Conditions Severe Aortic Valve Stenosis