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

Severe Aortic Valve Stenosis Clinical Trial

— BSC07  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05847751
• Other study ID #: MENA TAVI
• Status: Not yet recruiting
• Start date: January 2024
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: Ceric Sàrl
• Contact: Christophe LE ROUX, MSc
• Phone: +33 (0)7 60 27 80 98
• Email: cleroux[@]cerc-europe.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic
• Severe Aortic Valve Stenosis

Intervention

Device:
• Aortic valve replacement
Trans Aortic Valve Replacement (TAVI)

Locations

Country	Name	City	State
Egypt	Magdy Yacoub heart center	Aswan
Egypt	Ain shams Specialized hospital	Cairo
Egypt	Badr hospital	Cairo
Lebanon	American University of Beirut	Beirut
Saudi Arabia	King Fahad Armed Forces Hospital	Jeddah
Saudi Arabia	King Fahad National Guard Hospital	Riyadh
Saudi Arabia	National Guard Hospital - King Abdulaziz Medical City	Riyadh

Sponsors (2)

Lead Sponsor	Collaborator
Ceric Sàrl	European Cardiovascular Research Center

Countries where clinical trial is conducted

Egypt,  Lebanon,  Saudi Arabia, 

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* Note: There are 77 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality	All deaths reported	Post-procedure discharge of patient from the hospital (Preferably 1- 3 days post procedure)
Primary	Any stroke (disabling and non-disabling)	All stroke events	Post-procedure discharge of patient from the hospital (Preferably 1- 3 days post procedure)
Secondary	Technical success as defined by VARC-3	Combined endpoint composed of: Freedom from mortality; Successful access, delivery of the device, and retrieval of the delivery system; Correct positioning of a single prosthetic heart valve into the proper anatomical location; Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication	Post-procedure discharge of patient from the hospital (Preferably 1- 3 days post procedure)
Secondary	Device success as defined by VARC-3	Combined endpoint composed of: Technical success; Freedom from mortality; Freedom from surgery or intervention related to the device or to a major vascular or access related or cardiac structural complication; Intended performance of the valve (mean gradient <20mmHg, peak velocity <3 m/s, Doppler velocity index =0.25, and less than moderate aortic regurgitation)	Post-procedure discharge of patient from the hospital and at 30 days follow up
Secondary	Early safety as defined by VARC-3	Combined endpoint composed of: Freedom from all-cause mortality; Freedom from all stroke; Freedom from VARC 3 type 2-4 bleeding; Freedom from major vascular, access-related, or cardiac structural complication; Freedom from acute kidney injury stage 3 or 4; Freedom from moderate or severe aortic regurgitation; Freedom from new permanent pacemaker due to procedure related conduction abnormalities; Freedom from surgery or intervention related to the device	At 30 days
Secondary	Modified combined early safety and clinical efficacy at 30 days as defined by the Valve Academic research Consortium (VARC-2)	All cause death); All stroke (disabling and non-disabling); Acute kidney injury (Stage 1 or 2, including renal replacement therapy); Coronary artery obstruction requiring intervention; Major vascular complication; Valve related dysfunction requiring repeat procedure; Re-hospitalization for valve related symptoms or worsening congestive heart failure; Valve related dysfunction; Prosthetic aorta valve stenosis: mean aortic valve gradient >= 20 mmHg, effective orifice area (EOL) <= 1.1 cm2 (if body surface area >=1.6 m2) or <= 0.9 cm2 if BSA <1.6 m2 and/or Doppler velocity index <0.35; Moderate or severe prosthetic valve regurgitation according to VARC-2	At 30 days
Secondary	Clinical efficacy as defined by VARC-3	Combined endpoint composed of: Freedom from all-cause mortality; Freedom from all stroke; Freedom from hospitalization for procedure- or valve-related causes; Combined endpoint composed of: Freedom from all-cause mortality; Freedom from all stroke; Freedom from hospitalization for procedure- or valve-related causes	At 30 days
Secondary	All-cause mortality	All deaths reported	At 30 days
Secondary	Valve-related mortality	All deaths related to valve	At 30 days
Secondary	All stroke (ischaemic, haemorrhagic)	All stroke reported	At 30 days
Secondary	Hospitalization (or re-hospitalization)	All hospitalization reported	At 30 days
Secondary	Bleeding and transfusions (VARC3 type 1 - 4)	All bleeding events reported	At 30 days
Secondary	Bioprosthetic valve dysfunction	(structural, non structural, thrombosis, endocarditis): (Stage 1 to 3)	At 30 days
Secondary	Clinically significant prosthetic valve thrombosis	Valve related thrombosis	At 30 days
Secondary	Implantation of permanent pacemaker	Pacemaker implantation	At 30 days
Secondary	Occurrence of atrial fibrilation	atrial fbrillation reported	At 30 days