Prizvalve® Transcatheter Atrioventricular Valve Replacement Study

An Exploratory Study to Evaluate the Prizvalve® System in Patients With Severe Atrioventricular Annular Calcification or Failed Prosthetic Atrioventricular Valve/ Annulus Repair

To evaluate the safety and performance of the Prizvalve® system in patients with severe atrioventricular annular calcification or failed prosthetic atrioventricular valve/ annulus repair.

Study Overview

• Status: Recruiting
• Conditions: Atrioventricular Annular Calcification; Failed Prosthetic Atrioventricular Valve/ Annulus Repair
• Intervention / Treatment: Device: Prizvalve® system

Detailed Description

The Prizvalve® study is a single-center, single-arm, prospective, exploratory clinical study.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital
      • Contact: Wang chunsheng, Chief; Phone Number: 2512 (86)021-64041990; Email: cswang@medmail.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

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: Treatment; Transcatheter atrioventricular valve replacement with the Prizvalve® system	Device: Prizvalve® system; Transcatheter atrioventricular valve replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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+).	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days,1 year
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.	30 days,1 year
All-cause mortality	All-cause mortality included cardiac and non-cardiac death.	30 days,1 year

Collaborators and Investigators

• Sponsor: Shanghai NewMed Medical Co., Ltd.
• Collaborators: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2022
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): June 10, 2028

Study Registration Dates

• First Submitted: February 25, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 11, 2022

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: Metabolic Diseases; Calcium Metabolism Disorders; Calcinosis
• Other Study ID Numbers: P-valve-2021-12

Drug and device information, study documents

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