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Not yet recruiting NCT07122050

Prizvalve Transcatheter Aortic Valve in Failing Bioprosthetic Valves

No phase Interventional Failing Bioprosthetic Valves

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Prizvalve® system Transcatheter valve-in-valve replacement.
Who it may be relevant to
Registry conditions: Failing Bioprosthetic Valves. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Safety and Effectiveness of Prizvalve Transcatheter Aortic Valve in Patients With Failing Bioprosthetic Valves

Overview

The objective of this study is to evaluate the safety and effectiveness of the Prizvalve transcatheter aortic valve in subjects who are at high or greater risk with failing bioprosthetic valves.

Detailed description

Prospective, single arm, multicenter study

Interventions

  • Device Prizvalve® system Transcatheter valve-in-valve replacement
    Transcatheter valve-in-valve replacement procedure was performed according to standard clinical practice. Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system will be attempted.

Primary outcome measures

  • All-cause mortality [Time frame: At 30 days]
Secondary outcome measures (12)
  • Device success [Time frame: immediate post-surgical]
  • Procedural success [Time frame: immediate post-surgical]
  • All-cause mortality [Time frame: At 6 months, 1 year]
  • The incidence of rehospitalization [Time frame: At 30 days, 6 months, 1 year]
  • The incidence of myocardial infarction [Time frame: At 30 days, 6 months, 1 year]
  • The incidence of stroke [Time frame: At 30 days, 6 months, 1 year]
  • The incidence of bleeding [Time frame: At 30 days, 6 months, 1 year]
  • The incidence of acute kidney injury [Time frame: At 30 days, 6 months, 1 year]
  • The incidence of permanent pacemaker implantation [Time frame: At 30 days, 6 months, 1 year]
  • The incidence of vascular and access-related complications [Time frame: At 30 days, 6 months, 1 year]
  • The incidence of procedure-related complications [Time frame: At 30 days, 6 months, 1 year]
  • The incidence of valve dysfunction [Time frame: At 30 days, 6 months, 1 year]

Eligibility criteria

Inclusion criteria

Subjects must meet all of the following inclusion criteria to be eligible for participation:

  • Age≥18 years old;
  • Failing bioprosthetic valve (≥moderate stenosis and/or ≥moderate regurgitation);
  • NYHA Function Class≥ II;
  • Patient who is anatomically suitable for the implantation of the Prizvalve®;
  • According to heart team , patient is at high or greater surgical risk or not suitable for redo open heart surgery of valve replacement;
  • 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.

Exclusion criteria

  • Moderate or greater paravalvular regurgitation of the degenerated bioprosthetic valve；
  • Degenerated valve that cannot be securely fixed within the native annulus or exhibits structural incompleteness；
  • Anatomical features deemed unsuitable for transcatheter implantation.
  • Anatomical features that significantly increase the risk of left ventricular outflow tract (LVOT) obstruction；
  • Acute myocardial infarction within 30 days prior to enrollment；
  • Echocardiographic evidence of intracardiac mass, thrombus, or vegetation；
  • Active infective endocarditis or any other active infection；
  • Severe right ventricular dysfunction or severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20 %；
  • Inability to tolerate anticoagulant or antiplatelet therapy；
  • Cerebrovascular accident within 3 months prior to enrollment, excluding transient ischemic attack；
  • Refusal to undergo emergency cardiac surgery under any circumstances；
  • Participation in another drug or device clinical trial that has not yet reached its primary endpoint as of the time of enrollment；
  • Investigator-assessed poor compliance that would preclude adherence to protocol requirements；

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical Univer — Xi'an

Identifiers

NCT: NCT07122050 · Prizvalve-VIV-202504

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗