The objective of this study is to evaluate the ACURATE Neo2 in the Middle East population with severe, symptomatic aortic stenosis.
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.
Study Type
OBSERVATIONAL
Enrollment
51
Trans Aortic Valve Replacement (TAVI)
Magdy Yacoub heart center
Aswān, Egypt
Ain shams Specialized hospital
Cairo, Egypt
Badr hospital
Cairo, Egypt
American University of Beirut
Beirut, Lebanon
All cause mortality
All deaths reported
Time frame: Post-procedure discharge of patient from the hospital (Preferably 1- 3 days post procedure)
Any stroke (disabling and non-disabling)
All stroke events
Time frame: Post-procedure discharge of patient from the hospital (Preferably 1- 3 days post procedure)
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
Time frame: Post-procedure discharge of patient from the hospital (Preferably 1- 3 days post procedure)
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)
Time frame: Post-procedure discharge of patient from the hospital and at 30 days follow up
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
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King Fahad Armed Forces Hospital
Jeddah, Saudi Arabia
King Fahad National Guard Hospital
Riyadh, Saudi Arabia
National Guard Hospital - King Abdulaziz Medical City
Riyadh, Saudi Arabia
Time frame: At 30 days
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
Time frame: At 30 days
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
Time frame: At 30 days
All-cause mortality
All deaths reported
Time frame: At 30 days
Valve-related mortality
All deaths related to valve
Time frame: At 30 days
All stroke (ischaemic, haemorrhagic)
All stroke reported
Time frame: At 30 days
Hospitalization (or re-hospitalization)
All hospitalization reported
Time frame: At 30 days
Bleeding and transfusions (VARC3 type 1 - 4)
All bleeding events reported
Time frame: At 30 days
Bioprosthetic valve dysfunction
(structural, non structural, thrombosis, endocarditis): (Stage 1 to 3)
Time frame: At 30 days
Clinically significant prosthetic valve thrombosis
Valve related thrombosis
Time frame: At 30 days
Implantation of permanent pacemaker
Pacemaker implantation
Time frame: At 30 days
Occurrence of atrial fibrilation
atrial fbrillation reported
Time frame: At 30 days