Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study

NCT05864456 | Recruiting DMC

• 1 other identifier: Prizvalve Pro-2023
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to evaluate the safety and efficacy of the Prizvalve Pro™ 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)

• Composite endpoint event rate at 30 days

  Composite endpoint event includes all-cause death, stroke, myocardial infarction, permanent pacemaker implantation, serious vascular and access-related complications, surgical intervention for aortic valve reoperation, valve-in-valve surgery.

  30 days after procedure

Secondary Outcomes (15)

• Device success rate

  Immediately after procedure

• Procedural success rate

  Immediately after procedure

• Delivery system and component performance evaluation

  Immediately after procedure

• Valve function

  Immediately after procedure, 1 day of discharge, 30 days, 1 year

• Improvement in cardiac function

  1 day of discharge, 30 days, 1-5 year

Study Arms (1)

Transcatheter aortic valve replacement

EXPERIMENTAL

Transcatheter aortic valve replacement with Prizvalve Pro™ transcatheter aortic valve system

Device: Prizvalve Pro™ transcatheter aortic valve system

Interventions

Prizvalve Pro™ transcatheter aortic valve system DEVICE

Transcatheter Aortic Valve Replacement

Transcatheter aortic valve replacement

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);
• Cardiac function NYHA ≥ II;
• Life expectancy\> 12 months;
• Patients who are anatomically suitable for transcatheter aortic valve implantation;
• Patients who have been evaluated by two or more cardiovascular surgeons as unsuitable for conventional surgery; or patients who have refused conventional surgery after adequate communication from the surgeon and who are at high risk for conventional surgery;
• Patients who can understand the purpose of the trial and volunteer to participate in, sign the 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 unicuspid aortic valve;
• Patients with other prosthetic heart valves, prosthetic rings already implanted in the heart, or severe mitral valve closure insufficiency (\>3+);
• Patients with hematologic disorders or abnormalities that make surgical treatment inappropriate;
• 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;
• Patients with hypertrophic cardiomyopathy with obstruction;
• Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) \<20%;
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
• Patients with left ventricular outflow tract obstruction;
• A history of acute peptic ulcer or upper gastrointestinal bleeding within 3 months;
• Patients who are allergy or resistance to cobalt-chromium alloy, contrast agents and related components;
• Patients who are unable to receive anticoagulation or antiplatelet therapy;
• Cerebrovascular accident occurred within 3 months, not including transient ischemic attack;

Sponsors & Collaborators

• Shanghai NewMed Medical Co., Ltd.: lead
• The General Hospital of Northern Theater Command: collaborator
• West China Hospital: collaborator

Study Sites (1)

Shanghai NewMed Medical Co., Ltd.

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Yaling Han, Professor

  Principal coordinating investigator

  STUDY CHAIR

• Mao Chen, Professor

  coordinating investigator

  PRINCIPAL INVESTIGATOR

• Kai Xu, Professor

  coordinating investigator

  STUDY DIRECTOR

Central Study Contacts

Chunyang Wang

CONTACT

(86)-21-20788668; wang_chunyang@newmed.cn

Xuyang Xie

CONTACT

(86)-21-20788668

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: May 9, 2023
• First Posted: May 18, 2023
• Study Start: July 5, 2023
• Primary Completion: June 1, 2024
• Study Completion (Estimated): May 1, 2028
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)