Health TrialsbyHealthPanel

Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study

ConditionAortic Valve Stenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorShanghai NewMed Medical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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+);

Trial design

Design model

Single group

Treatments tested in this trial

  • Prizvalve Pro™ transcatheter aortic valve system

    Device

    Transcatheter Aortic Valve Replacement

Treatment groups

73 Participants
are divided into 1 treatment group
Group A: Transcatheter aortic valve replacementExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
30 days after procedure

Secondary outcomes

1

Device success rate

Device success is defined as 1. The device enters the vascular approach, be transported, released and implanted successfully, and the delivery system is removed from the body successfully; 2. 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
2

Procedural success rate

Procedure success is defined as 1. Implantation of ≤2 valves, with the implanted valves placed in the appropriate anatomic position; 2. No intraoperative or immediate postoperative mortality; 3. 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
3

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).

Time frame
Immediately after procedure
4

Valve function

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai NewMed Medical Co., Ltd.

Lead sponsor

The General Hospital of Northern Theater Command

Collaborator

West China Hospital

Collaborator

Source ClinicalTrials.gov
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