PrizValve® Transcatheter Aortic Valve Replacement Study

NCT04836897 | Active Not Recruiting DMC

• 1 other identifier: A-valve-2020-07
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are not suitable for surgery.

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• Freedom from all-cause mortality

  All-cause mortality within 12 months of TAVI procedure

  12 months

Secondary Outcomes (6)

• Freedom from all-cause mortality

  2-5 years

• Device success

  immediate post-surgical

• Procedural success

  immediate post-surgical

• Rate of Myocardial infarction

  30 days、6 months、1-5 years

• Rate of All disabling stroke

  30 days、6 months、1-5 years

Study Arms (1)

Treatment

EXPERIMENTAL

Transcatheter aortic valve replacement

Device: PrizValve® valve and transapical delivery system

Interventions

PrizValve® valve and transapical delivery system DEVICE

Transcatheter aortic valve replacement system

Treatment

Eligibility Criteria

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

You may qualify if:

• Age ≥ 65 years ;
• Patients with symptomatic severe aortic valve stenosis (evaluated by echocardiography: transaortic valve pressure gradient ≥40mmHg (1mmHg=0.133kPa), or transaortic valve blood flow rate ≥4m/s, or aortic Valve area\<1.0cm2, or AVA \<0.5cm2 /m2);
• NYHA ≥ II;
• Life expectancy\> 12 months;
• Patients who are anatomically suitable for transcatheter aortic valve implantation;
• After evaluation by two or more cardiovascular surgeons, patients who are unsuitable for surgery; or patients who refuse surgery after sufficient communication by the surgeons and are at high risk of routine surgery;
• Patients who can understand the purpose of the trial, voluntarily participate in and signed informed consent form, and are willing to accept relevant examinations and clinical follow-ups.

You may not qualify if:

• Acute myocardial infarction occurred within 1 month before this treatment;
• Congenital single leaf aortic valve;
• Any therapeutic cardiac operation (including placement of coronary drug-eluting stents) within 30 days;
• The patient's heart has been implanted with other artificial heart valves, artificial rings, or severe mitral regurgitation (\>3+);
• Blood system diseases or abnormalities, including leukopenia (WBC\<3×109/L), acute anemia (HB \<90g/L), thrombocytopenia (PLT\<50×109/L), bleeding constitution and coagulopathy ；
• Untreated severe coronary artery stenosis that requires revascularization;
• Patients with hemodynamic or respiratory instability, requiring continuous mechanical heart assistance or mechanical ventilation;
• Patients who need emergency surgery for any reason;
• Hypertrophic cardiomyopathy with obstruction;
• Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) \<20%;
• The echocardiogram indicates the presence of a heart mass, thrombus or vegetation;
• A history of acute peptic ulcer or upper gastrointestinal bleeding within 3 months;
• Are allergic to cobalt-chromium alloys or contrast agents, and cannot tolerate anticoagulation and antiplatelet therapy;
• The diameter of the aortic valve annulus \<16mm or \>28mm;
• In any case, patients who refuse surgical treatment in emergency situations;

Sponsors & Collaborators

• Shanghai NewMed Medical Co., Ltd.: lead

Study Sites (1)

Department of Cardiology, West China Hospital, Sichuan University

Sichuan, 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 Officials

• Chen mao, Chief

  Study Principal Investigator

  STUDY CHAIR

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: April 6, 2021
• First Posted: April 8, 2021
• Study Start: January 19, 2021
• Primary Completion: June 19, 2023
• Study Completion (Estimated): June 1, 2028
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)