Clinical trial NCT05847751: The Use of ACURATE Neo 2 Valve in Patients With Symptomatic Aortic Valve Stenosis
Official title: The Use of ACURATE Neo 2 Valve in Patients With Symptomatic Aortic Valve Stenosis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Severe Aortic Valve Stenosis
Lead sponsor: Ceric Sàrl
Sponsor class: INDUSTRY
Collaborators: name: European Cardiovascular Research Center
First posted: 2023-05-08
Enrollment: 51
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 100 patients from Middle East population with severe, symptomatic aortic stenosis will be enrolled

Brief summary: The objective of this study is to evaluate the ACURATE Neo2 in the Middle East population with severe, symptomatic aortic stenosis.

Detailed description: The MENA-TAVI study is an investigator-initiated, prospective, single-arm observational trial.

Patients referred for or presenting with severe aortic stenosis requiring an intervention constitute the source population. The Heart Team consisting of interventional cardiologists and cardiovascular surgeons will evaluate the patients by integrating the available clinical data, the predicted 30-day mortality, individual factors affecting mortality such as frailty as well as the estimated life-expectancy and the patient's wishes to finally reach a consensus on the optimal treatment strategy with regards to transcatheter or surgical aortic valve replacement. Patients planned for TAVI will be screened for eligibility. If patients fulfill all inclusion and do not meet exclusion criteria, they will be informed about the study's purpose and course and will be asked for participation and written informed consent. In case of consent, they will be treated by the ACURATE neo2 aortic bioprosthesis.

At discharge and at 30 days, the clinical outcomes composing the primary safety endpoint will be captured. Additional clinical, procedural and echocardiographic data will be obtained at discharge and at 30 days for assessment of secondary endpoints.

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

Primary outcomes:
measure: All cause mortality
timeFrame: Post-procedure discharge of patient from the hospital (Preferably 1- 3 days post procedure)
measure: Any stroke (disabling and non-disabling)
timeFrame: Post-procedure discharge of patient from the hospital (Preferably 1- 3 days post procedure)
Secondary outcomes:
measure: Technical success as defined by VARC-3
timeFrame: Post-procedure discharge of patient from the hospital (Preferably 1- 3 days post procedure)
measure: Device success as defined by VARC-3
timeFrame: Post-procedure discharge of patient from the hospital and at 30 days follow up
measure: Early safety as defined by VARC-3
timeFrame: At 30 days
measure: Modified combined early safety and clinical efficacy at 30 days as defined by the Valve Academic research Consortium (VARC-2)
timeFrame: At 30 days
measure: Clinical efficacy as defined by VARC-3
timeFrame: At 30 days
measure: All-cause mortality
timeFrame: At 30 days
measure: Valve-related mortality
timeFrame: At 30 days
measure: All stroke (ischaemic, haemorrhagic)
timeFrame: At 30 days
measure: Hospitalization (or re-hospitalization)
timeFrame: At 30 days
measure: Bleeding and transfusions (VARC3 type 1 - 4)
timeFrame: At 30 days
measure: Bioprosthetic valve dysfunction
timeFrame: At 30 days
measure: Clinically significant prosthetic valve thrombosis
timeFrame: At 30 days
measure: Implantation of permanent pacemaker
timeFrame: At 30 days
measure: Occurrence of atrial fibrilation
timeFrame: At 30 days
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Magdy Yacoub heart center
city: Cairo
country: Egypt
facility: Ain shams Specialized hospital
city: Cairo
country: Egypt
facility: Badr hospital
city: Beirut
country: Lebanon
facility: American University of Beirut
city: Jeddah
country: Saudi Arabia
facility: King Fahad Armed Forces Hospital
city: Riyadh
country: Saudi Arabia
facility: King Fahad National Guard Hospital
city: Riyadh
country: Saudi Arabia
facility: National Guard Hospital - King Abdulaziz Medical City
Study officials:
affiliation: King Fahad National Guard Hospital
name: Mohamed BALGHITH, MD
role: PRINCIPAL_INVESTIGATOR
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