VitaFlow™ Transcatheter Aortic Valve System Pre-market Trial

Aortic Valve Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04655742
• Other study ID #: valve-2014-04
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

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