Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study

Evaluation of the Safety and Efficacy of the Prizvalve Pro™ Transcatheter Aortic Valve System in the Treatment of Patients With Severe Aortic Valve Stenosis Disease at High Surgical Risk

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: Prizvalve Pro™ transcatheter aortic valve system

Detailed Description

This study is a multicenter, single-arm, prospective clinical study.

• Study Type: Interventional
• Enrollment (Estimated): 73
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chunyang Wang; Phone Number: (86)-21-20788668; Email: wang_chunyang@newmed.cn
• Study Contact Backup: Name: Xuyang Xie; Phone Number: (86)-21-20788668

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai NewMed Medical Co., Ltd.
    • Contact: Xuyang Xie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 65 years ;
2. 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);
3. Cardiac function NYHA ≥ II;
4. Life expectancy> 12 months;
5. Patients who are anatomically suitable for transcatheter aortic valve implantation;
6. 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;
7. 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.

Exclusion Criteria:

1. Acute myocardial infarction occurred within 1 month before this treatment;
2. Congenital unicuspid aortic valve;
3. Any therapeutic cardiac operation that is performed within 30 days of the index procedure (Previous PCI or implantation of a permanent pacemaker are not considered exclusion criteria);
4. Patients with other prosthetic heart valves, prosthetic rings already implanted in the heart, or severe mitral valve closure insufficiency (>3+);
5. Patients with hematologic disorders or abnormalities that make surgical treatment inappropriate;
6. Untreated severe coronary artery stenosis that requires revascularization;
7. Patients with hemodynamic or respiratory instability, requiring continuous mechanical heart assistance or mechanical ventilation;
8. Patients who need emergency surgery for any reason;
9. Patients with hypertrophic cardiomyopathy with obstruction;
10. Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) <20%;
11. Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
12. Patients with left ventricular outflow tract obstruction;
13. A history of acute peptic ulcer or upper gastrointestinal bleeding within 3 months;
14. Patients who are allergy or resistance to cobalt-chromium alloy, contrast agents and related components;
15. Patients who are unable to receive anticoagulation or antiplatelet therapy;
16. Cerebrovascular accident occurred within 3 months, not including transient ischemic attack;
17. Severe aortic diseases, including abdominal aortic or thoracic aortic aneurysm, etc;
18. Active infective endocarditis or other active infections;
19. Patients who have participated in clinical trials of other drugs or medical devices before enrollment and have not yet reached the primary outcome of research;
20. The investigator judged that patient with poor compliance and could not complete the study as required.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcatheter aortic valve replacement; Transcatheter aortic valve replacement with Prizvalve Pro™ transcatheter aortic valve system	Device: Prizvalve Pro™ transcatheter aortic valve system; Transcatheter Aortic Valve Replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device success rate	Device success is defined as; The device enters the vascular approach, be transported, released and implanted successfully, and the delivery system is removed from the body successfully;; The implanted valve achieves the desired efficacy (mean transvalvular pressure difference <20 mmHg or peak flow velocity <3 m/s in the aortic valve, no severe prosthetic aortic regurgitation or perivalvular leak).	Immediately after procedure
Procedural success rate	Procedure success is defined as; Implantation of ≤2 valves, with the implanted valves placed in the appropriate anatomic position;; No intraoperative or immediate postoperative mortality;; The intended purpose of the procedure was achieved without serious intraoperative complications (coronary occlusion, septal perforation, mitral valve damage or incompetence, pericardial tamponade, surgical termination, and open-heart surgical treatment for cardiac surgery).	Immediately after procedure
Valve function	Valve function includes aortic orifice area, transvalvular pressure difference, valvular regurgitation, and perivalvular leakage.	Immediately after procedure, 1 day of discharge, 30 days, 1 year
Improvement in cardiac function	Cardiac function is based on the New York Heart Association (NYHA) classification scheme.	1 day of discharge, 30 days, 1-5 year
Improvement in quality of life	The SF-12 rating scale is used to assess quality of life.	30 days, 1 year
Incidence of all-cause mortality	Rate of all-cause mortality during the trial. All-cause mortality includes cardiovascular morality and non-cardiovascular morality.	Immediately after procedure, 1 day of discharge, 30 days, 1-5 year
Incidence of myocardial infarction	Rate of patients with myocardial infarction during the trial.	Immediately after procedure, 1 day of discharge, 30 days, 1-5 year
Incidence of disabling stroke	Rate of patients with disabling stroke during the trial.	1 day of discharge, 30 days, 1-5 year
Incidence of permanent pacemaker implantation	Rate of patients with permanent pacemaker implantation during the trial.	1 day of discharge, 30 days, 1-5 year
Incidence of serious vascular and access-related complications	Rate of patients with serious vascular and access-related complications during the trial.	Immediately after procedure, 1 day of discharge, 30 days, 1-5 year
Incidence of serious bleeding	Rate of patients with serious bleeding during the trial.	1 day of discharge, 30 days, 1-5 year
Incidence of acute kidney injury	Rate of patients with acute kidney injury during the trial.	1 day of discharge, 30 days, 1-5 year
Incidence of major cardiovascular and cerebrovascular adverse events	Incidence of MACCE during the trial. MACCE is defined as death, stroke, myocardial infarction, arrhythmia, conduction block, and aortic valve reoperation (interventional or surgical).	1 day of discharge, 30 days, 1-5 year
Incidence of other TAVI-related complications	Rate of patients with other TAVI-related complications during the trial. Other TAVI-related complications include conversion to surgery, valve-in-valve implantation, accidental cardiopulmonary mechanical assistance, coronary occlusion, ventricular septal perforation, mitral valve damage or loss of function, pericardial tamponade, endocarditis, valvular thrombosis, valvular ectopic (migration, embolization, erroneous release), etc.	Immediately after procedure, 1 day of discharge, 30 days, 1-5 year
Delivery system and component performance evaluation	Delivery system performance evaluation includes delivery, transvalve, release positioning, balloon filling and retrieval, visibility, and retrieval performance. (For each assessment: 1-4 points；1=excellent, 2=good, 3=fair, 4=poor).	Immediately after procedure

Collaborators and Investigators

• Sponsor: Shanghai NewMed Medical Co., Ltd.
• Collaborators: West China Hospital; The General Hospital of Northern Theater Command
• Investigators: Study Chair: Yaling Han, Professor, Principal Coordinating Investigator; Principal Investigator: Mao Chen, Professor, Coordinating Investigator; Study Director: Kai Xu, Professor, Coordinating Investigator

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: May 9, 2023
• First Submitted That Met QC Criteria: May 17, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: Prizvalve Pro-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No