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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05847751
Other study ID # MENA TAVI
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.


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Study Design


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, 

References & Publications (77)

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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
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