search
Back to results

Prizvalve® Transcatheter Atrioventricular Valve Replacement Study

Primary Purpose

Atrioventricular Annular Calcification, Failed Prosthetic Atrioventricular Valve/ Annulus Repair

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Prizvalve® 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 Atrioventricular Annular Calcification

Eligibility Criteria

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

1. Inclusion criteria for patients with severe atrioventricular valve annular calcification:

  1. Atrioventricular valve annular calcification with moderate or severe atrioventricular valve disease (stenosis, regurgitation, or mixed);
  2. Patient with symptoms, and NYHA Functional Class≥Ⅱ;
  3. 18 years and older who is not in pregnancy or lactation;
  4. Life expectancy>12 months;
  5. Patient who is anatomically suitable for transcatheter atrioventricular valve replacement;
  6. According to the evaluation of the heart team, the patient can benefit from transcatheter atrioventricular valve replacement;
  7. The patient can understand the purpose of the trial, voluntarily participate in and sign the informed consent form, and is willing to accept relevant examinations and clinical follow-ups;
  8. Patient with high risk of routine surgery (STS>8%) or severe comorbidities that is not suitable for surgery, or with severely calcified valve annulus that cannot be operated.

2. Inclusion criteria for patients with failed prosthetic atrioventricular valve/annulus repair:

  1. The patient has undergone atrioventricular valve replacement or valve annulus repair in the past, accompanied by severe atrioventricular valve regurgitation or stenosis;
  2. The patient is symptomatic with NYHA Functional Class≥II or hemolytic anemia requiring blood transfusion (no other causes of hemolytic anemia were found after examination);
  3. 18 years and older who is not in pregnancy or lactation;
  4. Patient who is anatomically suitable for transcatheter atrioventricular valve replacement;
  5. According to the evaluation of the heart team, the patient can benefit from transcatheter atrioventricular valve replacement;
  6. The patient can understand the purpose of the trial, voluntarily participate in and sign the informed consent form, and is willing to accept relevant examinations and clinical follow-ups;
  7. Patient with high risk of routine surgery (STS>8%) or severe comorbidities that is not suitable for surgery.

Exclusion criteria:

  1. Evidence of an acute myocardial infarction <1 month(30 days) before the intended treatment;
  2. Any therapeutic cardiac operation (excluding previous PCI and pacemaker implantation) is performed within 30 days of the index procedure;
  3. Patient with planned concomitant surgical or transcatheter ablation for atrial fibrillation;
  4. Patient with hypertrophic cardiomyopathy with obstruction;
  5. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) <20%;
  6. Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
  7. Acute peptic ulcer or upper gastrointestinal bleeding within 3 months prior to procedure;
  8. Allergy to cobalt-chromium alloy or contrast agent; inability to tolerate anticoagulation and antiplatelet therapy;
  9. Active stage of infective endocarditis or other active infection;
  10. Cerebrovascular accident within 3 months prior to procedure, excluding transient ischemic attack;
  11. Patient with poor compliance and could not complete the study as required.

Sites / Locations

  • Zhongshan HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Transcatheter atrioventricular valve replacement with the Prizvalve® system

Outcomes

Primary Outcome Measures

Technical success
Definition: Freedom from death; Successful vascular delivery and retrieval of transcatheter valve delivery system; Correct position of transcatheter valve; No need for any emergency surgery or re-intervention (including device-related and surgical approach-related); Adequate performance of prosthesis (mean pressure gradient (MVG) <10mmHg, valve regurgitation <2+).

Secondary Outcome Measures

Procedural Success
Device success; No SAE's including: death; stroke; life threatening bleeding; major vascular complications; secondary severe cardiac organic disease (eg: aortic dissection, apical aneurysm formation, left ventricular outflow tract obstruction, etc.); stage 2 or 3 AKI; MI or coronary ischemia requiring PCI or CABG; severe hypotension; heart failure or respiratory failure requiring high-dose vasoactive drugs/or cardiac mechanical assist devices; any valve-related dysfunction including migration, thrombosis, or other complication requiring surgery or repeat intervention.
Device success
Definitions: Freedom from stroke; Prosthetic heart valve function is normal (including no displacement, calcification, thrombosis, hemolysis, or endocarditis); No need for any emergency surgery or secondary intervention (including device-related and surgical approach-related); No atrioventricular valve stenosis (mean pressure gradient <10mmHg); Atrioventricular valve regurgitation <2+ (including central leakage and paravalvular leakage), and no related hemolysis; LVOT pressure gradient increased <20mmHg.
All-cause mortality
All-cause mortality included cardiac and non-cardiac death.

Full Information

First Posted
February 25, 2022
Last Updated
March 20, 2023
Sponsor
Shanghai NewMed Medical Co., Ltd.
Collaborators
Shanghai Zhongshan Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05275088
Brief Title
Prizvalve® Transcatheter Atrioventricular Valve Replacement Study
Official Title
An Exploratory Study to Evaluate the Prizvalve® System in Patients With Severe Atrioventricular Annular Calcification or Failed Prosthetic Atrioventricular Valve/ Annulus Repair
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2022 (Actual)
Primary Completion Date
June 10, 2023 (Anticipated)
Study Completion Date
June 10, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai NewMed Medical Co., Ltd.
Collaborators
Shanghai Zhongshan 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
To evaluate the safety and performance of the Prizvalve® system in patients with severe atrioventricular annular calcification or failed prosthetic atrioventricular valve/ annulus repair.
Detailed Description
The Prizvalve® study is a single-center, single-arm, prospective, exploratory clinical study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrioventricular Annular Calcification, Failed Prosthetic Atrioventricular Valve/ Annulus Repair

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Transcatheter atrioventricular valve replacement with the Prizvalve® system
Intervention Type
Device
Intervention Name(s)
Prizvalve® system
Intervention Description
Transcatheter atrioventricular valve replacement
Primary Outcome Measure Information:
Title
Technical success
Description
Definition: Freedom from death; Successful vascular delivery and retrieval of transcatheter valve delivery system; Correct position of transcatheter valve; No need for any emergency surgery or re-intervention (including device-related and surgical approach-related); Adequate performance of prosthesis (mean pressure gradient (MVG) <10mmHg, valve regurgitation <2+).
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Procedural Success
Description
Device success; No SAE's including: death; stroke; life threatening bleeding; major vascular complications; secondary severe cardiac organic disease (eg: aortic dissection, apical aneurysm formation, left ventricular outflow tract obstruction, etc.); stage 2 or 3 AKI; MI or coronary ischemia requiring PCI or CABG; severe hypotension; heart failure or respiratory failure requiring high-dose vasoactive drugs/or cardiac mechanical assist devices; any valve-related dysfunction including migration, thrombosis, or other complication requiring surgery or repeat intervention.
Time Frame
30 days,1 year
Title
Device success
Description
Definitions: Freedom from stroke; Prosthetic heart valve function is normal (including no displacement, calcification, thrombosis, hemolysis, or endocarditis); No need for any emergency surgery or secondary intervention (including device-related and surgical approach-related); No atrioventricular valve stenosis (mean pressure gradient <10mmHg); Atrioventricular valve regurgitation <2+ (including central leakage and paravalvular leakage), and no related hemolysis; LVOT pressure gradient increased <20mmHg.
Time Frame
30 days,1 year
Title
All-cause mortality
Description
All-cause mortality included cardiac and non-cardiac death.
Time Frame
30 days,1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
1. Inclusion criteria for patients with severe atrioventricular valve annular calcification: Atrioventricular valve annular calcification with moderate or severe atrioventricular valve disease (stenosis, regurgitation, or mixed); Patient with symptoms, and NYHA Functional Class≥Ⅱ; 18 years and older who is not in pregnancy or lactation; Life expectancy>12 months; Patient who is anatomically suitable for transcatheter atrioventricular valve replacement; According to the evaluation of the heart team, the patient can benefit from transcatheter atrioventricular valve replacement; The patient can understand the purpose of the trial, voluntarily participate in and sign the informed consent form, and is willing to accept relevant examinations and clinical follow-ups; Patient with high risk of routine surgery (STS>8%) or severe comorbidities that is not suitable for surgery, or with severely calcified valve annulus that cannot be operated. 2. Inclusion criteria for patients with failed prosthetic atrioventricular valve/annulus repair: The patient has undergone atrioventricular valve replacement or valve annulus repair in the past, accompanied by severe atrioventricular valve regurgitation or stenosis; The patient is symptomatic with NYHA Functional Class≥II or hemolytic anemia requiring blood transfusion (no other causes of hemolytic anemia were found after examination); 18 years and older who is not in pregnancy or lactation; Patient who is anatomically suitable for transcatheter atrioventricular valve replacement; According to the evaluation of the heart team, the patient can benefit from transcatheter atrioventricular valve replacement; The patient can understand the purpose of the trial, voluntarily participate in and sign the informed consent form, and is willing to accept relevant examinations and clinical follow-ups; Patient with high risk of routine surgery (STS>8%) or severe comorbidities that is not suitable for surgery. Exclusion criteria: Evidence of an acute myocardial infarction <1 month(30 days) before the intended treatment; Any therapeutic cardiac operation (excluding previous PCI and pacemaker implantation) is performed within 30 days of the index procedure; Patient with planned concomitant surgical or transcatheter ablation for atrial fibrillation; Patient with hypertrophic cardiomyopathy with obstruction; Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) <20%; Echocardiographic evidence of intracardiac mass, thrombus or vegetation; Acute peptic ulcer or upper gastrointestinal bleeding within 3 months prior to procedure; Allergy to cobalt-chromium alloy or contrast agent; inability to tolerate anticoagulation and antiplatelet therapy; Active stage of infective endocarditis or other active infection; Cerebrovascular accident within 3 months prior to procedure, excluding transient ischemic attack; Patient with poor compliance and could not complete the study as required.
Facility Information:
Facility Name
Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang chunsheng, Chief
Phone
(86)021-64041990
Ext
2512
Email
cswang@medmail.com.cn

12. IPD Sharing Statement

Learn more about this trial

Prizvalve® Transcatheter Atrioventricular Valve Replacement Study

We'll reach out to this number within 24 hrs