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VitaFlow™ Transcatheter Aortic Valve System Pre-market Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04655742
Recruitment Status : Active, not recruiting
First Posted : December 7, 2020
Last Update Posted : December 7, 2020
Sponsor:
Information provided by (Responsible Party):
Shanghai MicroPort CardioFlow Medtech Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Device: VitaFlow™ Transcatheter Aortic Valve System Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 27, 2014
Actual Primary Completion Date : September 6, 2017
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: single arm, treatment group
Subjects in the treatment group will be implanted with the VitaFlow™ Transcatheter Aortic Valve System
 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


Outcome Measures
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Primary Outcome Measures :
  1. Rate of device success-Phase I [ Time Frame: at immediate post-procedure ]
  2. All-cause mortality at 12 months post implantation-Phase II [ Time Frame: at 12 months post-procedure ]

Secondary Outcome Measures :
  1. Rate of major adverse events -Phase I [ Time Frame: at 30 days post implantation ]
  2. Hemodynamic performance-Phase II [ Time Frame: 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)

  3. Heart function(NYHA)-Phase II [ Time Frame: at immediate post-procedure, discharge, 30 days, 6 months, 1 year and annually up to 5 years post implantation ]
  4. Rate of safety events according to VARC2-Phase II [ Time Frame: at immediate, 30 days, 1 year and annually up to 5 years post implantation ]
  5. Rate of major cardiovascular and cerebrovascular events(MACCE)-Phase II [ Time Frame: at immediate, 30 days, 1 year and annually up to 5 years post implantation ]
  6. Rate of balloon pre-dilatation success-Phase II [ Time Frame: at immediate post implantation ]
  7. Rate of balloon post-dilatation success-Phase II [ Time Frame: at immediate post implantation ]

Eligibility Criteria
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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04655742


Locations
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China, Beijing
Fuwai Hospital
Beijing, Beijing, China
China, Shanghai
Zhongshan Hospital Fudan University
Shanghai, Shanghai, China
China, Sichuan
West China Hospital of Sichuan University
Chengdu, Sichuan, China
China, Zhejiang
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Sponsors and Collaborators
Shanghai MicroPort CardioFlow Medtech Co., Ltd.
More Information
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Responsible Party: Shanghai MicroPort CardioFlow Medtech Co., Ltd.
ClinicalTrials.gov Identifier: NCT04655742    
Other Study ID Numbers: valve-2014-04
First Posted: December 7, 2020    Key Record Dates
Last Update Posted: December 7, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Aortic Valve Disease
 Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction