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Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study

Primary Purpose

Aortic Valve Stenosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Prizvalve Pro™ transcatheter aortic valve system
Sponsored by
Shanghai NewMed Medical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: Acute myocardial infarction occurred within 1 month before this treatment; Congenital unicuspid aortic valve; 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); 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; Severe aortic diseases, including abdominal aortic or thoracic aortic aneurysm, etc; Active infective endocarditis or other active infections; 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; The investigator judged that patient with poor compliance and could not complete the study as required.

Sites / Locations

  • Shanghai NewMed Medical Co., Ltd.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcatheter aortic valve replacement

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).
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).
Valve function
Valve function includes aortic orifice area, transvalvular pressure difference, valvular regurgitation, and perivalvular leakage.
Improvement in cardiac function
Cardiac function is based on the New York Heart Association (NYHA) classification scheme.
Improvement in quality of life
The SF-12 rating scale is used to assess quality of life.
Incidence of all-cause mortality
Rate of all-cause mortality during the trial. All-cause mortality includes cardiovascular morality and non-cardiovascular morality.
Incidence of myocardial infarction
Rate of patients with myocardial infarction during the trial.
Incidence of disabling stroke
Rate of patients with disabling stroke during the trial.
Incidence of permanent pacemaker implantation
Rate of patients with permanent pacemaker implantation during the trial.
Incidence of serious vascular and access-related complications
Rate of patients with serious vascular and access-related complications during the trial.
Incidence of serious bleeding
Rate of patients with serious bleeding during the trial.
Incidence of acute kidney injury
Rate of patients with acute kidney injury during the trial.
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).
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.

Full Information

First Posted
May 9, 2023
Last Updated
June 20, 2023
Sponsor
Shanghai NewMed Medical Co., Ltd.
Collaborators
The General Hospital of Northern Theater Command, West China Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05864456
Brief Title
Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 29, 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
May 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai NewMed Medical Co., Ltd.
Collaborators
The General Hospital of Northern Theater Command, West China Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcatheter aortic valve replacement
Arm Type
Experimental
Arm Description
Transcatheter aortic valve replacement with Prizvalve Pro™ transcatheter aortic valve system
Intervention Type
Device
Intervention Name(s)
Prizvalve Pro™ transcatheter aortic valve system
Intervention Description
Transcatheter Aortic Valve Replacement
Primary Outcome Measure Information:
Title
Composite endpoint event rate at 30 days
Description
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.
Time Frame
30 days after procedure
Secondary Outcome Measure Information:
Title
Device success rate
Description
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).
Time Frame
Immediately after procedure
Title
Procedural success rate
Description
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).
Time Frame
Immediately after procedure
Title
Delivery system and component performance evaluation
Description
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).
Time Frame
Immediately after procedure
Title
Valve function
Description
Valve function includes aortic orifice area, transvalvular pressure difference, valvular regurgitation, and perivalvular leakage.
Time Frame
Immediately after procedure, 1 day of discharge, 30 days, 1 year
Title
Improvement in cardiac function
Description
Cardiac function is based on the New York Heart Association (NYHA) classification scheme.
Time Frame
1 day of discharge, 30 days, 1-5 year
Title
Improvement in quality of life
Description
The SF-12 rating scale is used to assess quality of life.
Time Frame
30 days, 1 year
Title
Incidence of all-cause mortality
Description
Rate of all-cause mortality during the trial. All-cause mortality includes cardiovascular morality and non-cardiovascular morality.
Time Frame
Immediately after procedure, 1 day of discharge, 30 days, 1-5 year
Title
Incidence of myocardial infarction
Description
Rate of patients with myocardial infarction during the trial.
Time Frame
Immediately after procedure, 1 day of discharge, 30 days, 1-5 year
Title
Incidence of disabling stroke
Description
Rate of patients with disabling stroke during the trial.
Time Frame
1 day of discharge, 30 days, 1-5 year
Title
Incidence of permanent pacemaker implantation
Description
Rate of patients with permanent pacemaker implantation during the trial.
Time Frame
1 day of discharge, 30 days, 1-5 year
Title
Incidence of serious vascular and access-related complications
Description
Rate of patients with serious vascular and access-related complications during the trial.
Time Frame
Immediately after procedure, 1 day of discharge, 30 days, 1-5 year
Title
Incidence of serious bleeding
Description
Rate of patients with serious bleeding during the trial.
Time Frame
1 day of discharge, 30 days, 1-5 year
Title
Incidence of acute kidney injury
Description
Rate of patients with acute kidney injury during the trial.
Time Frame
1 day of discharge, 30 days, 1-5 year
Title
Incidence of major cardiovascular and cerebrovascular adverse events
Description
Incidence of MACCE during the trial. MACCE is defined as death, stroke, myocardial infarction, arrhythmia, conduction block, and aortic valve reoperation (interventional or surgical).
Time Frame
1 day of discharge, 30 days, 1-5 year
Title
Incidence of other TAVI-related complications
Description
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.
Time Frame
Immediately after procedure, 1 day of discharge, 30 days, 1-5 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Acute myocardial infarction occurred within 1 month before this treatment; Congenital unicuspid aortic valve; 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); 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; Severe aortic diseases, including abdominal aortic or thoracic aortic aneurysm, etc; Active infective endocarditis or other active infections; 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; The investigator judged that patient with poor compliance and could not complete the study as required.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunyang Wang
Phone
(86)-21-20788668
Email
wang_chunyang@newmed.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xuyang Xie
Phone
(86)-21-20788668
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaling Han, Professor
Organizational Affiliation
Principal coordinating investigator
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mao Chen, Professor
Organizational Affiliation
coordinating investigator
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kai Xu, Professor
Organizational Affiliation
coordinating investigator
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai NewMed Medical Co., Ltd.
City
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuyang Xie

12. IPD Sharing Statement

Plan to Share IPD
No

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Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study

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