VitaFlow™ Transcatheter Aortic Valve System Pre-market Trial

Brief Title

VitaFlow™ Transcatheter Aortic Valve System Pre-market 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

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.

Study Type

Interventional

Primary Outcome

Rate of device success-Phase I

Secondary Outcome

 Rate of major adverse events -Phase I

Condition

Aortic Valve Stenosis

Intervention

VitaFlow™ Transcatheter Aortic Valve System

Study Arms / Comparison Groups

 single arm, treatment group

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

Start Date

June 27, 2014

Completion Date

December 31, 2021

Primary Completion Date

September 6, 2017

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.

Gender

All

Ages

70 Years - N/A

Accepts Healthy Volunteers

No

Contacts

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Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT04655742

Organization ID

valve-2014-04

Responsible Party

Sponsor

Study Sponsor

Shanghai MicroPort CardioFlow Medtech Co., Ltd.

Study Sponsor

, ,

Verification Date

November 2020