VitaFlow™ Transcatheter Aortic Valve System Pre-market Trial

NCT ID: NCT04655742

Last Updated: 2020-12-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-27
• Study Completion Date: 2021-12-31

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.

Conditions

Aortic Valve Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single arm, treatment group

Subjects in the treatment group will be implanted with the VitaFlow™ Transcatheter Aortic Valve System

Group Type: EXPERIMENTAL

VitaFlow™ Transcatheter Aortic Valve System

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai MicroPort CardioFlow Medtech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fuwai Hospital

Beijing, Beijing Municipality, China

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

valve-2014-04

Identifier Type: -

Identifier Source: org_study_id