Aortic Valve Stenosis
Conditions
Brief summary
This is a pre-market clinical investigation aiming to evaluate the safety and effectiveness of MicroPort™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.
Detailed description
This is a prospective, multi-center, single-arm clinical investigation for evaluation of the safety and effectiveness of the MicroPort™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System in the Treatment of Severe Aortic Stenosis. The investigation has two phases. Phase I（FIM）：The FIM stage is a prospective, multicenter, single-arm observational clinical investigation, aiming to evaluate the feasibility and safety of the MicroPort™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System. A total of 10 patients will be enrolled and 30-day clinical outcomes will be collected. Phase II (Pivotal)：The pivotal stage is a prospective, multi-center, single-arm clinical investigation with the performance goal, aiming to evaluate the safety and effectiveness of MicroPort™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis. A total of 110 patients will be enrolled in 11 clinical centers across China. Clinical or telephone follow-up is scheduled at 30 days, 6 months, 12 months, and 2 to 5 years annually post-procedure.
Interventions
VitaFlow™ Transcatheter Aortic Valve System contains a valve stent-VitaFlow™ Aortic Valve, a delivery system-VitaFlow™ Delivery System,loading tools, a balloon dilatation catheter, and an introducer set
Sponsors
Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
: Enrollment was limited to patients who met all of the following criteria: 1. Age ≥ 70 years old(Phase II)/Age ≥18 years old,male or female who are not pregnant (Phase I); 2. Patients have severe aortic stenosis: Mean gradient\> 40mmHg(1mmHg = 0.133kPa), or peak velocity\> 4m/s, or an aortic valve area(AVA) \<1.0 cm² (or AVA index \<0.6 cm²/m²); 3. NYHA classification ≥ II; 4. Life expectancy\> 12 months; 5. Anatomically suitable for transcatheter aortic valve implantation; 6. Assessed by a multidisciplinary heart team as a patient unsuitable for surgical aortic valve replacement; 7. Patients who can understand the purpose of the investigation, volunteer to participate in and sign the informed consent form, and are willing to comply with relevant examinations and follow-up visits.
Exclusion criteria
1. Acute myocardial infarction occurred within 30 days before the treatment; 2. Patients with congenital unicuspid aortic valve or aortic root anatomy and lesions that are not suitable for transcatheter valve implantation; 3. Any therapeutic heart surgery within 30 days; 4. Mixed aortic valve disease(aortic stenosis with severe regurgitation); moderate and severe mitral stenosis; severe mitral regurgitation; severe tricuspid regurgitation; 5. Blood dyscrasia, including neutropenia (WBC \< 3 × 10\^9/L), acute anemia(HB \<90 g/L), thrombocytopenia(PLT \<50 × 10\^9/L), hemorrhagic constitution, and coagulopathy disease; 6. Untreated coronary artery disease requiring revascularization; 7. Hemodynamic instability requiring systolic support or mechanical heart assistance; 8. Need for emergency surgery for any reason; 9. Obstructive hypertrophic cardiomyopathy; 10. Severe left ventricular dysfunction, left ventricular ejection fraction(LVEF) \< 20%; severe pulmonary hypertension and right ventricular dysfunction; 11. Echocardiography suggests the presence of intracardiac masses, thrombi, or neoplasms; 12. Active peptic ulcer or history of upper gastrointestinal bleeding within 3 months; 13. Allergy to aspirin, heparin, ticlopidine, clopidogrel, nitinol, or contrast agents; 14. Cerebrovascular events including transient ischemic attack(TIA) occurred within 6 months; 15. Renal insufficiency decompensation(end creatinine clearance \< 20ml/min), and / or end-stage renal disease require long-term dialysis treatment; 16. Vascular diseases affecting device access; 17. Active infectious endocarditis or other active infection; 18. Participated in clinical investigations of other drugs or medical devices before the election, and had not completed the primary endpoint; 19. The investigator judged that the patient had poor compliance and could not complete the study as required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of device success-Phase I | at immediate post-procedure |
| All-cause mortality at 12 months post implantation-Phase II | at 12 months post-procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart function(NYHA)-Phase II | at immediate post-procedure, discharge, 30 days, 6 months, 1 year and annually up to 5 years post implantation | — |
| Rate of safety events according to VARC2-Phase II | at immediate, 30 days, 1 year and annually up to 5 years post implantation | — |
| Rate of major adverse events -Phase I | at 30 days post implantation | — |
| Rate of balloon pre-dilatation success-Phase II | at immediate post implantation | — |
| Rate of balloon post-dilatation success-Phase II | at immediate post implantation | — |
| Rate of major cardiovascular and cerebrovascular events(MACCE)-Phase II | at immediate, 30 days, 1 year and annually up to 5 years post implantation | — |
| Hemodynamic performance-Phase II | at immediate post-procedure, discharge, 30 days, 6 months, 1 year and annually up to 5 years post implantation | Hemodynamic performance, including the mean prosthetic valve gradient(in mmHg), the Effective orifice(in cm\^2), and the degree of prosthetic valve regurgitation measured by transthoracic echocardiography (TTE) |
Countries
China
Outcome results
None listed