Status:
UNKNOWN
All Women Comparing Self-expanding ALLEGRA Valve to Any Other Balloon-expandable Valve
Lead Sponsor:
Ceric Sàrl
Collaborating Sponsors:
Biosensors International
European Cardiovascular Research Center
Conditions:
Aortic Stenosis, Severe
Eligibility:
FEMALE
75+ years
Phase:
NA
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...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT05989074
Start Date
February 1 2024
End Date
August 31 2025
Last Update
January 12 2024
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