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All Women Comparing Self-expanding ALLEGRA Valve to Any Other Balloon-expandable Valve

Primary Purpose

Aortic Stenosis, Severe

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ALLEGRA TAVI System TF
Ballon-expandable valve system
Sponsored by
Ceric Sàrl
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Aortic Stenosis, Severe

Eligibility Criteria

75 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Female sex Age ≥ 75 years (according to ESC/EACTS, Guidelines for the management of valvular heart disease) Severe calcific aortic valve stenosis defined as follows: high-gradient aortic stenosis (mean pressure gradient across aortic valve > 40 mmHg or peak velocity > 4.0 m/s) Symptomatic aortic valve stenosis with New York Heart Association (NYHA) Class ≥II ECG-gated Multi-Slice Computed Tomographic (MSCT) measurements determined an aortic annulus perimeter-derived average diameter >19 mm and <27.4 mm or area-derived diameter >18 and <28 mm Anatomy suitable for trans-femoral TAVI for both devices used in the study, including a minimum femoral diameter of 6 mm. Subject with a documented local Heart Team (HT) indication for TF TAVI Life expectancy longer than 1 year. Willingness to undergo clinical and echocardiographic follow-up after the procedure. Subject can understand the purpose of the clinical investigation, has signed voluntarily the informed consent form and is agreeing to the scheduled follow-up requirements Exclusion Criteria: Male sex Non-calcific acquired aortic stenosis Native unicuspid/bicuspid aortic valve or congenital aortic abnormality Previous implantation of heart valve in any position Severe aortic regurgitation (> 3+) Severe mitral regurgitation (> 3+) Severe tricuspid regurgitation (> 3+) Severe left ventricular dysfunction (Left Ventricular Ejection Fraction (LVEF) < 30%) Echocardiographic evidence of intracardiac mass, thrombus or vegetation Untreated cardiac conduction disease in need of pacemaker implantation Evidence of acute Myocardial Infarction (MI) less than 30 days before signing informed consent Any need for emergency surgery Any active bleeding that precludes anticoagulation Liver failure (Child-C) End-stage renal disease requiring chronic dialysis or creatinine clearance < 30cc/min Pulmonary hypertension (systolic pressure > 80mmHg) A known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens (or inability to be anticoagulated for the index procedure), to cobalt chromium, to bovine and/or collagen, glutaraldehyde or contrast media Any medical, social or psychological condition that in the opinion of the investigator precludes the subject from giving appropriate consent or adherence to the required follow-up procedures Currently participating in another drug or device trial (excluding observational registries) for which the primary endpoint has not been assessed Subject under judicial protection, tutorship or curatorship (for France only)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    ALLEGRA

    Balloon-expandable TAVI

    Arm Description

    ALLEGRA Delivery System TF will be administered.Patient will receive Anticoagulation medication according to the site-specific standard of care

    Patient will receive any kind of CE-marked balloon-expandable valve, and anticoagulation medication according to the site-specific standard of care

    Outcomes

    Primary Outcome Measures

    Trans-aortic mean gradient measured by TTE 30 days after the TAVI procedure.
    Trans-aortic mean gradient measured by TTE 30 days after the TAVI procedure.

    Secondary Outcome Measures

    Technical success assessed by composite criteria
    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
    Device success assessed by composite criteria
    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 <20 mmHg, peak velocity <3 m/s, Doppler velocity index ≥ 0.25, and less than moderate aortic regurgitation)
    Early safety assessed by composite criteria
    Freedom from all-cause mortality Freedom from all stroke Freedom from Valve Academic Research Consortium (VARC) type 2-4 bleeding (in trials where control group is surgery, it is appropriate to include only Type 3 and 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
    Clinical efficacy assessed by composite criteria
    Freedom from all-cause mortality Freedom from all stroke Freedom from hospitalization for procedure- or valve-related causes Freedom from Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score <45 or decline from baseline of >10 point (i.e. Unfavourable Outcome)

    Full Information

    First Posted
    July 25, 2023
    Last Updated
    August 17, 2023
    Sponsor
    Ceric Sàrl
    Collaborators
    Biosensors International, European Cardiovascular Research Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05989074
    Brief Title
    All Women Comparing Self-expanding ALLEGRA Valve to Any Other Balloon-expandable Valve
    Official Title
    All Women A Multicenter Randomized Clinical Trial Comparing Self-expanding ALLEGRA Valve to Any Other Balloon-expandable Valve in a Women Population
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    August 31, 2025 (Anticipated)
    Study Completion Date
    August 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ceric Sàrl
    Collaborators
    Biosensors International, European Cardiovascular Research Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Study is aimed to demonstrate that the self-expandable Allegra TAVI system provides lower mean gradient assessed by TTE compared to balloon-expandable valve systems in a female patient population with symptomatic severe aortic stenosis
    Detailed Description
    Study is aimed to demonstrate that the self-expandable Allegra transcatheter aortic valve implantation (TAVI) system provides lower mean gradient assessed by Transthoracic Echo (TTE) at 30 days post procedure, compared to balloon-expandable valve systems in a female patient population with symptomatic severe aortic stenosis. Patients in both arm will receive anticoagulants according to routine practice of the hospital. Patients will be followed-up until 1 year after the procedure.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aortic Stenosis, Severe

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    130 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ALLEGRA
    Arm Type
    Experimental
    Arm Description
    ALLEGRA Delivery System TF will be administered.Patient will receive Anticoagulation medication according to the site-specific standard of care
    Arm Title
    Balloon-expandable TAVI
    Arm Type
    Active Comparator
    Arm Description
    Patient will receive any kind of CE-marked balloon-expandable valve, and anticoagulation medication according to the site-specific standard of care
    Intervention Type
    Device
    Intervention Name(s)
    ALLEGRA TAVI System TF
    Intervention Description
    Patients receive ALLEGRA TAVI System TF. Patient will receive medication according to routine practice of the hospital
    Intervention Type
    Device
    Intervention Name(s)
    Ballon-expandable valve system
    Intervention Description
    Patients receive any kind of CE-marked balloon expandable valve system, used at the hospital. Patient will receive medication according to routine practice of the hospital.
    Primary Outcome Measure Information:
    Title
    Trans-aortic mean gradient measured by TTE 30 days after the TAVI procedure.
    Description
    Trans-aortic mean gradient measured by TTE 30 days after the TAVI procedure.
    Time Frame
    At 30 Days
    Secondary Outcome Measure Information:
    Title
    Technical success assessed by composite criteria
    Description
    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
    Up to the end of the time when patient exit the procedure room
    Title
    Device success assessed by composite criteria
    Description
    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 <20 mmHg, peak velocity <3 m/s, Doppler velocity index ≥ 0.25, and less than moderate aortic regurgitation)
    Time Frame
    At 30 days
    Title
    Early safety assessed by composite criteria
    Description
    Freedom from all-cause mortality Freedom from all stroke Freedom from Valve Academic Research Consortium (VARC) type 2-4 bleeding (in trials where control group is surgery, it is appropriate to include only Type 3 and 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
    Time Frame
    At 30 days
    Title
    Clinical efficacy assessed by composite criteria
    Description
    Freedom from all-cause mortality Freedom from all stroke Freedom from hospitalization for procedure- or valve-related causes Freedom from Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score <45 or decline from baseline of >10 point (i.e. Unfavourable Outcome)
    Time Frame
    At 1 year

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Biological gender
    Minimum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Female sex Age ≥ 75 years (according to ESC/EACTS, Guidelines for the management of valvular heart disease) Severe calcific aortic valve stenosis defined as follows: high-gradient aortic stenosis (mean pressure gradient across aortic valve > 40 mmHg or peak velocity > 4.0 m/s) Symptomatic aortic valve stenosis with New York Heart Association (NYHA) Class ≥II ECG-gated Multi-Slice Computed Tomographic (MSCT) measurements determined an aortic annulus perimeter-derived average diameter >19 mm and <27.4 mm or area-derived diameter >18 and <28 mm Anatomy suitable for trans-femoral TAVI for both devices used in the study, including a minimum femoral diameter of 6 mm. Subject with a documented local Heart Team (HT) indication for TF TAVI Life expectancy longer than 1 year. Willingness to undergo clinical and echocardiographic follow-up after the procedure. Subject can understand the purpose of the clinical investigation, has signed voluntarily the informed consent form and is agreeing to the scheduled follow-up requirements Exclusion Criteria: Male sex Non-calcific acquired aortic stenosis Native unicuspid/bicuspid aortic valve or congenital aortic abnormality Previous implantation of heart valve in any position Severe aortic regurgitation (> 3+) Severe mitral regurgitation (> 3+) Severe tricuspid regurgitation (> 3+) Severe left ventricular dysfunction (Left Ventricular Ejection Fraction (LVEF) < 30%) Echocardiographic evidence of intracardiac mass, thrombus or vegetation Untreated cardiac conduction disease in need of pacemaker implantation Evidence of acute Myocardial Infarction (MI) less than 30 days before signing informed consent Any need for emergency surgery Any active bleeding that precludes anticoagulation Liver failure (Child-C) End-stage renal disease requiring chronic dialysis or creatinine clearance < 30cc/min Pulmonary hypertension (systolic pressure > 80mmHg) A known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens (or inability to be anticoagulated for the index procedure), to cobalt chromium, to bovine and/or collagen, glutaraldehyde or contrast media Any medical, social or psychological condition that in the opinion of the investigator precludes the subject from giving appropriate consent or adherence to the required follow-up procedures Currently participating in another drug or device trial (excluding observational registries) for which the primary endpoint has not been assessed Subject under judicial protection, tutorship or curatorship (for France only)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nozomi Watanabe
    Phone
    +33 (0)6 61 38 94 80
    Email
    nwatanabe@cerc-europe.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Laure Morsiani
    Phone
    +33 (0)1 76 73 92 36
    Email
    lmorsiani@cerc-europe.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alaide Chieffo, Prof
    Organizational Affiliation
    Ospedale San Raffaele
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ignacio Cruz-Gonzalez, Prof
    Organizational Affiliation
    University of Salamanca
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    All Women Comparing Self-expanding ALLEGRA Valve to Any Other Balloon-expandable Valve

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