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New treatment option for Aortic Valve Stenosis
Official title Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study
ClinicalTrials.gov ID: NCT05864456
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- Age ≥ 65 years ;
- Patients with symptomatic severe aortic valve stenosis (evaluated by echocardiography: transaortic valve pressure gradient ≥40mmHg (1mmHg=0.133kPa)...
- Cardiac function NYHA ≥ II;
- Life expectancy\> 12 months;
- Patients who are anatomically suitable for transcatheter aortic valve implantation;
You likely can't join if
- 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...
- Patients with other prosthetic heart valves, prosthetic rings already implanted in the heart, or severe mitral valve closure insufficiency (\>3+);
- Patients with hematologic disorders or abnormalities that make surgical treatment inappropriate;
- Untreated severe coronary artery stenosis that requires revascularization;
See the full eligibility criteria
- 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...
- Cardiac function NYHA ≥ II;
- Life expectancy\> 12 months;
- Patients who are anatomically suitable for transcatheter aortic valve implantation;
- Patients who have been evaluated by two or more cardiovascular surgeons as unsuitable for conventional surgery; or patients who have refused conventional surgery after adequate communication from the surgeon and who are...
- Patients who can understand the purpose of the trial and volunteer to participate in, sign the informed consent form and are willing to accept relevant examinations and clinical follow-ups.
- 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+);
- Patients with hematologic disorders or abnormalities that make surgical treatment inappropriate;
- Untreated severe coronary artery stenosis that requires revascularization;
- Patients with hemodynamic or respiratory instability, requiring continuous mechanical heart assistance or mechanical ventilation;
- Patients who need emergency surgery for any reason;
- Patients with hypertrophic cardiomyopathy with obstruction;
- Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) \<20%;
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
- Patients with left ventricular outflow tract obstruction;
- A history of acute peptic ulcer or upper gastrointestinal bleeding within 3 months;
- Patients who are allergy or resistance to cobalt-chromium alloy, contrast agents and related components;
- Patients who are unable to receive anticoagulation or antiplatelet therapy;
- Cerebrovascular accident occurred within 3 months, not including transient ischemic attack;
- Severe aortic diseases, including abdominal aortic or thoracic aortic aneurysm, etc;
- Active infective endocarditis or other active infections;
- Patients who have participated in clinical trials of other drugs or medical devices before enrollment and have not yet reached the primary outcome of research;
- The investigator judged that patient with poor compliance and could not complete the study as required.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.