Evaluating the ACURATE Neo 2 Valve for Severe Aortic Valve Stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• 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

Study contacts

• Principal investigator: Mohamed BALGHITH, MD — King Fahad National Guard Hospital
• Study coordinator: Christophe LE ROUX, MSc
• Email: cleroux@cerc-europe.org
• Phone: +33 (0)7 60 27 80 98

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Hydra THV Transfemoral Valve Implantation in Severe Aortic Stenosis

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• Registry for patients with severe aortic valve stenosis undergoing TAVR with Myval valve

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• Comparing heart valve prostheses for treating aortic stenosis

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• Personalized antithrombotic therapy for patients after aortic valve replacement

  This study is testing if a personalized blood-thinning treatment can help people who have had aortic valve replacement feel better and avoid complications compared to standard treatment.

  Recruiting St. Antonius Hospital · Nieuwegein · NCT06168370

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.