Prizvalve® Transcatheter Valve-in-Valve Implantation Exploratory Study

NCT05652062 | Unknown

• 1 other identifier: Prizvalve-VIV-2022
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this clinical trial is to evaluate the efficacy and safety of the transcatheter aortic valve system in the treatment of patients with failing bioprosthetic valve

Conditions

Failing Bioprosthetic Valve

Outcome Measures

Primary Outcomes (1)

• Composite of all-cause mortality and valve-related reintervention

  1 year

Secondary Outcomes (4)

• Technical success

  30 days

• Procedural Success

  30 days

• Device success

  30 days

• All-cause mortality

  30 days

Study Arms (1)

Treatment

EXPERIMENTAL

Device: Prizvalve® system

Interventions

Prizvalve® system DEVICE

Transcatheter valve-in-valve replacement

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Failing bioprosthetic valve (≥moderate stenosis and/or ≥moderate regurgitation);
• Age≥18 years old who are not in pregnancy or lactation;
• NYHA Function Class≥ II;
• Patient who is anatomically suitable for the implantation of the Prizvalve® ;
• According to heart team , patient is intermediate or above surgical risk or not suitable for redo open heart surgery of valve replacement due to other severe comorbidities ;
• Heart team agrees valve implantation will likely benefit the patient;
• Patient understands the purpose of the trial and volunteers to participate in, sign the informed consent form and is willing to accept relevant examinations and clinical follow-ups.

You may not qualify if:

• Patients with other valvular diseases that require simultaneous intervention;
• Patients with other heart diseases that require simultaneous intervention;
• Estimated life expectancy \< 12 months;
• Failing valve has moderate and above paravalvular regurgitation;
• Failing valve in unstable ore not structurally intact;
• Increased risk of coronary artery obstruction by prosthetic leaflets of the failing valve;
• Anatomical characteristics that would preclude transcatheter valve implantation;
• Anatomical characteristics that would increase the risk of left ventricular outflow tract (LVOT) obstruction;
• Patient with acute myocardial infarction within 30 days;
• Any therapeutic cardiac operation (excluding previous PCI and pacemaker implantation) is performed within 30 days of the index procedure;
• Patient with hypertrophic cardiomyopathy with obstruction;
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
• Patients with active infective endocarditis or other active infections;
• Patients with severe right ventricular dysfunction, or severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) \< 20%;
• Patients who cannot tolerate anticoagulant or antiplatelet therapy;

Sponsors & Collaborators

• Shanghai NewMed Medical Co., Ltd.: lead
• Shanghai Zhongshan Hospital: collaborator

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

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: December 8, 2022
• First Posted: December 15, 2022
• Study Start: June 2, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 2, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

CN (1)