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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04655742
Other study ID # valve-2014-04
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 27, 2014
Est. completion date December 31, 2021

Study information

Verified date November 2020
Source Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 120
Est. completion date December 31, 2021
Est. primary completion date September 6, 2017
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
VitaFlow™ Transcatheter Aortic Valve System
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

Locations

Country Name City State
China Fuwai Hospital Beijing Beijing
China West China Hospital of Sichuan University Chengdu Sichuan
China The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou Zhejiang
China Zhongshan Hospital Fudan University Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai MicroPort CardioFlow Medtech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of device success-Phase I at immediate post-procedure
Primary All-cause mortality at 12 months post implantation-Phase II at 12 months post-procedure
Secondary Rate of major adverse events -Phase I at 30 days post implantation
Secondary Hemodynamic performance-Phase II 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) at immediate post-procedure, discharge, 30 days, 6 months, 1 year and annually up to 5 years post implantation
Secondary Heart function(NYHA)-Phase II at immediate post-procedure, discharge, 30 days, 6 months, 1 year and annually up to 5 years post implantation
Secondary Rate of safety events according to VARC2-Phase II at immediate, 30 days, 1 year and annually up to 5 years post implantation
Secondary Rate of major cardiovascular and cerebrovascular events(MACCE)-Phase II at immediate, 30 days, 1 year and annually up to 5 years post implantation
Secondary Rate of balloon pre-dilatation success-Phase II at immediate post implantation
Secondary Rate of balloon post-dilatation success-Phase II at immediate post implantation
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