The Use of ACURATE Neo 2 Valve in Patients With Symptomatic Aortic Valve Stenosis (BSC07)

October 18, 2023 updated by: Ceric Sàrl
The objective of this study is to evaluate the ACURATE Neo2 in the Middle East population with severe, symptomatic aortic stenosis.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Aswan, Egypt
        • Magdy Yacoub heart center
        • Contact:
          • Ahmed Elguindy, MD
      • Cairo, Egypt
        • Ain Shams Specialized Hospital
        • Contact:
          • Ahmed El Sayed, MD
      • Cairo, Egypt
        • Badr hospital
        • Contact:
          • Yasser Sadek, MD
  • Lebanon
      • Beirut, Lebanon
        • American University of Beirut
        • Contact:
          • fadi Sawaya, MD
  • Saudi Arabia
      • Jeddah, Saudi Arabia
        • King Fahad Armed Forces Hospital
        • Contact:
          • Khaled Al Shaibi
      • Riyadh, Saudi Arabia
        • King Fahad National Guard Hospital
        • Contact:
      • Riyadh, Saudi Arabia
        • National Guard Hospital - King Abdulaziz Medical City
        • Contact:
          • Wail Alkashkari, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

A total of 100 patients from Middle East population with severe, symptomatic aortic stenosis will be enrolled

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause mortality
Time Frame: Post-procedure discharge of patient from the hospital (Preferably 1- 3 days post procedure)
All deaths reported
Post-procedure discharge of patient from the hospital (Preferably 1- 3 days post procedure)
Any stroke (disabling and non-disabling)
Time Frame: Post-procedure discharge of patient from the hospital (Preferably 1- 3 days post procedure)
All stroke events
Post-procedure discharge of patient from the hospital (Preferably 1- 3 days post procedure)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success as defined by VARC-3
Time Frame: Post-procedure discharge of patient from the hospital (Preferably 1- 3 days post procedure)

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)
Device success as defined by VARC-3
Time Frame: Post-procedure discharge of patient from the hospital and at 30 days follow up

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
Early safety as defined by VARC-3
Time Frame: At 30 days

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
Modified combined early safety and clinical efficacy at 30 days as defined by the Valve Academic research Consortium (VARC-2)
Time Frame: At 30 days
  • 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
Clinical efficacy as defined by VARC-3
Time Frame: At 30 days

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
All-cause mortality
Time Frame: At 30 days
All deaths reported
At 30 days
Valve-related mortality
Time Frame: At 30 days
All deaths related to valve
At 30 days
All stroke (ischaemic, haemorrhagic)
Time Frame: At 30 days
All stroke reported
At 30 days
Hospitalization (or re-hospitalization)
Time Frame: At 30 days
All hospitalization reported
At 30 days
Bleeding and transfusions (VARC3 type 1 - 4)
Time Frame: At 30 days
All bleeding events reported
At 30 days
Bioprosthetic valve dysfunction
Time Frame: At 30 days
(structural, non structural, thrombosis, endocarditis): (Stage 1 to 3)
At 30 days
Clinically significant prosthetic valve thrombosis
Time Frame: At 30 days
Valve related thrombosis
At 30 days
Implantation of permanent pacemaker
Time Frame: At 30 days
Pacemaker implantation
At 30 days
Occurrence of atrial fibrilation
Time Frame: At 30 days
atrial fbrillation reported
At 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ceric Sàrl

Collaborators

European Cardiovascular Research Center

Investigators

  • Principal Investigator: Mohamed BALGHITH, MD, King Fahad National Guard Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

March 1, 2023

First Submitted That Met QC Criteria

May 4, 2023

First Posted (Actual)

May 8, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MENA TAVI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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