VitaFlow™ Transcatheter Aortic Valve System Pre-market Trial

NCT04655742 | Unknown

• 1 other identifier: valve-2014-04
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

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.

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (2)

• Rate of device success-Phase I

  at immediate post-procedure

• All-cause mortality at 12 months post implantation-Phase II

  at 12 months post-procedure

Secondary Outcomes (7)

• Rate of major adverse events -Phase I

  at 30 days post implantation

• Hemodynamic performance-Phase II

  at immediate post-procedure, discharge, 30 days, 6 months, 1 year and annually up to 5 years post implantation

• Heart function(NYHA)-Phase II

  at immediate post-procedure, discharge, 30 days, 6 months, 1 year and annually up to 5 years post implantation

• Rate of safety events according to VARC2-Phase II

  at immediate, 30 days, 1 year and annually up to 5 years post implantation

• Rate of major cardiovascular and cerebrovascular events(MACCE)-Phase II

  at immediate, 30 days, 1 year and annually up to 5 years post implantation

Study Arms (1)

single arm, treatment group

EXPERIMENTAL

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

Device: VitaFlow™ Transcatheter Aortic Valve System

Interventions

VitaFlow™ Transcatheter Aortic Valve System 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

single arm, treatment group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Enrollment was limited to patients who met all of the following criteria:
• Age ≥ 70 years old(Phase II)/Age ≥18 years old,male or female who are not pregnant (Phase I);
• 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);
• NYHA classification ≥ II;
• Life expectancy\> 12 months;
• Anatomically suitable for transcatheter aortic valve implantation;
• Assessed by a multidisciplinary heart team as a patient unsuitable for surgical aortic valve replacement;
• 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.

You may not qualify if:

• Acute myocardial infarction occurred within 30 days before the treatment;
• Patients with congenital unicuspid aortic valve or aortic root anatomy and lesions that are not suitable for transcatheter valve implantation;
• Any therapeutic heart surgery within 30 days;
• Mixed aortic valve disease(aortic stenosis with severe regurgitation); moderate and severe mitral stenosis; severe mitral regurgitation; severe tricuspid regurgitation;
• 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;
• Untreated coronary artery disease requiring revascularization;
• Hemodynamic instability requiring systolic support or mechanical heart assistance;
• Need for emergency surgery for any reason;
• Obstructive hypertrophic cardiomyopathy;
• Severe left ventricular dysfunction, left ventricular ejection fraction(LVEF) \< 20%; severe pulmonary hypertension and right ventricular dysfunction;
• Echocardiography suggests the presence of intracardiac masses, thrombi, or neoplasms;
• Active peptic ulcer or history of upper gastrointestinal bleeding within 3 months;
• Allergy to aspirin, heparin, ticlopidine, clopidogrel, nitinol, or contrast agents;
• Cerebrovascular events including transient ischemic attack(TIA) occurred within 6 months;
• Renal insufficiency decompensation(end creatinine clearance \< 20ml/min), and / or end-stage renal disease require long-term dialysis treatment;

Sponsors & Collaborators

• Shanghai MicroPort CardioFlow Medtech Co., Ltd.: lead

Study Sites (4)

Fuwai Hospital

Beijing, Beijing Municipality, China

Location

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 7, 2020
• Study Start: June 27, 2014
• Primary Completion: September 6, 2017
• Study Completion: December 31, 2021
• Last Updated: December 7, 2020

Record last verified: 2020-11

Locations

CN (4)