All Women Comparing Self-expanding ALLEGRA Valve to Any Other Balloon-expandable Valve
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ALLEGRA ALLEGRA Delivery System TF will be administered.Patient will receive Anticoagulation medication according to the site-specific standard of care |
Device: ALLEGRA TAVI System TF
Patients receive ALLEGRA TAVI System TF. Patient will receive medication according to routine practice of the hospital
|
| Active Comparator: Balloon-expandable TAVI Patient will receive any kind of CE-marked balloon-expandable valve, and anticoagulation medication according to the site-specific standard of care |
Device: Ballon-expandable valve system
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.
|
Outcome Measures
Primary Outcome Measures
- Trans-aortic mean gradient measured by TTE 30 days after the TAVI procedure. [1 year]
Trans-aortic mean gradient measured by TTE 30 days after the TAVI procedure.
Secondary Outcome Measures
- Technical success assessed by composite criteria [Up to the end of the time when patient exit the procedure room]
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 [At 30 days]
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 [At 30 days]
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 [At 1 year and thereafter]
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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Female sex
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Age ≥ 75 years (according to ESC/EACTS, Guidelines for the management of valvular heart disease)
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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
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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
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Anatomy suitable for trans-femoral TAVI for both devices used in the study, including a minimum femoral diameter of 6 mm.
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Subject with a documented local Heart Team (HT) indication for TF TAVI
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Life expectancy longer than 1 year.
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Willingness to undergo clinical and echocardiographic follow-up after the procedure.
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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:
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Male sex
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Non-calcific acquired aortic stenosis
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Native unicuspid/bicuspid aortic valve or congenital aortic abnormality
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Previous implantation of heart valve in any position
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Severe aortic regurgitation (> 3+)
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Severe mitral regurgitation (> 3+)
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Severe tricuspid regurgitation (> 3+)
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Severe left ventricular dysfunction (Left Ventricular Ejection Fraction (LVEF) < 30%)
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Echocardiographic evidence of intracardiac mass, thrombus or vegetation
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Untreated cardiac conduction disease in need of pacemaker implantation
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Evidence of acute Myocardial Infarction (MI) less than 30 days before signing informed consent
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Any need for emergency surgery
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Any active bleeding that precludes anticoagulation
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Liver failure (Child-C)
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End-stage renal disease requiring chronic dialysis or creatinine clearance < 30cc/min
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Pulmonary hypertension (systolic pressure > 80mmHg)
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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
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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
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Currently participating in another drug or device trial (excluding observational registries) for which the primary endpoint has not been assessed
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Subject under judicial protection, tutorship or curatorship (for France only)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Ceric Sàrl
- Biosensors International
- European Cardiovascular Research Center
Investigators
- Principal Investigator: Alaide Chieffo, Prof, Ospedale San Raffaele
- Principal Investigator: Ignacio Cruz-Gonzalez, Prof, University of Salamanca
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BSR-14