Aortic Stenosis, Severe
Conditions
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.
Interventions
DEVICEALLEGRA TAVI System TF
Patients receive ALLEGRA TAVI System TF. Patient will receive medication according to routine practice of the hospital
DEVICEBallon-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.
Sponsors
Biosensors International
European Cardiovascular Research Center
Ceric Sàrl
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female sex 2. Age ≥ 75 years (according to ESC/EACTS, Guidelines for the management of valvular heart disease) 3. 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 4. 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 5. Anatomy suitable for trans-femoral TAVI for both devices used in the study, including a minimum femoral diameter of 6 mm. 6. Subject with a documented local Heart Team (HT) indication for TF TAVI 7. Life expectancy longer than 1 year. 8. Willingness to undergo clinical and echocardiographic follow-up after the procedure. 9. 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
1. Male sex 2. Non-calcific acquired aortic stenosis 3. Native unicuspid/bicuspid aortic valve or congenital aortic abnormality 4. Previous implantation of heart valve in any position 5. Severe aortic regurgitation (\> 3+) 6. Severe mitral regurgitation (\> 3+) 7. Severe tricuspid regurgitation (\> 3+) 8. Severe left ventricular dysfunction (Left Ventricular Ejection Fraction (LVEF) \< 30%) 9. Echocardiographic evidence of intracardiac mass, thrombus or vegetation 10. Untreated cardiac conduction disease in need of pacemaker implantation 11. Evidence of acute Myocardial Infarction (MI) less than 30 days before signing informed consent 12. Any need for emergency surgery 13. Any active bleeding that precludes anticoagulation 14. Liver failure (Child-C) 15. End-stage renal disease requiring chronic dialysis or creatinine clearance \< 30cc/min 16. Pulmonary hypertension (systolic pressure \> 80mmHg) 17. 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 18. 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 19. Currently participating in another drug or device trial (excluding observational registries) for which the primary endpoint has not been assessed 20. Subject under judicial protection, tutorship or curatorship (for France only)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trans-aortic mean gradient measured by TTE 30 days after the TAVI procedure. | At 30 Days | Trans-aortic mean gradient measured by TTE 30 days after the TAVI procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | * 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) |
Contacts
Primary ContactNozomi Watanabe
Backup ContactLaure Morsiani
Outcome results
None listed