Clinical trial NCT05864456: Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study
Official title: Evaluation of the Safety and Efficacy of the Prizvalve Pro™ Transcatheter Aortic Valve System in the Treatment of Patients With Severe Aortic Valve Stenosis Disease at High Surgical Risk
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Valve Stenosis
Lead sponsor: Shanghai NewMed Medical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: The General Hospital of Northern Theater Command
name: West China Hospital
First posted: 2023-05-18
Enrollment: 73
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This study is a multicenter, single-arm, prospective clinical study.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 65 years ;
2. 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);
3. Cardiac function NYHA ≥ II;
4. Life expectancy\> 12 months;
5. Patients who are anatomically suitable for transcatheter aortic valve implantation;
6. 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 at high risk for conventional surgery;
7. 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.

Exclusion Criteria:

1. Acute myocardial infarction occurred within 1 month before this treatment;
2. Congenital unicuspid aortic valve;
3. 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);
4. Patients with other prosthetic heart valves, prosthetic rings already implanted in the heart, or severe mitral valve closure insufficiency (\>3+);
5. Patients with hematologic disorders or abnormalities that make surgical treatment inappropriate;
6. Untreated severe coronary artery stenosis that requires revascularization;
7. Patients with hemodynamic or respiratory instability, requiring continuous mechanical heart assistance or mechanical ventilation;
8. Patients who need emergency surgery for any reason;
9. Patients with hypertrophic cardiomyopathy with obstruction;
10. Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) \<20%;
11. Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
12. Patients with left ventricular outflow tract obstruction;
13. A history of acute peptic ulcer or upper gastrointestinal bleeding within 3 months;
14. Patients who are allergy or resistance to cobalt-chromium alloy, contrast agents and related components;
15. Patients who are unable to receive anticoagulation or antiplatelet therapy;
16. Cerebrovascular accident occurred within 3 months, not including transient ischemic attack;
17. Severe aortic diseases, including abdominal aortic or thoracic aortic aneurysm, etc;
18. Active infective endocarditis or other active infections;
19. 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;
20. The investigator judged that patient with poor compliance and could not complete the study as required.

Primary outcomes:
measure: Composite endpoint event rate at 30 days
timeFrame: 30 days after procedure
Secondary outcomes:
measure: Device success rate
timeFrame: Immediately after procedure
measure: Procedural success rate
timeFrame: Immediately after procedure
measure: Delivery system and component performance evaluation
timeFrame: Immediately after procedure
measure: Valve function
timeFrame: Immediately after procedure, 1 day of discharge, 30 days, 1 year
measure: Improvement in cardiac function
timeFrame: 1 day of discharge, 30 days, 1-5 year
measure: Improvement in quality of life
timeFrame: 30 days, 1 year
measure: Incidence of all-cause mortality
timeFrame: Immediately after procedure, 1 day of discharge, 30 days, 1-5 year
measure: Incidence of myocardial infarction
timeFrame: Immediately after procedure, 1 day of discharge, 30 days, 1-5 year
measure: Incidence of disabling stroke
timeFrame: 1 day of discharge, 30 days, 1-5 year
measure: Incidence of permanent pacemaker implantation
timeFrame: 1 day of discharge, 30 days, 1-5 year
measure: Incidence of serious vascular and access-related complications
timeFrame: Immediately after procedure, 1 day of discharge, 30 days, 1-5 year
measure: Incidence of serious bleeding
timeFrame: 1 day of discharge, 30 days, 1-5 year
measure: Incidence of acute kidney injury
timeFrame: 1 day of discharge, 30 days, 1-5 year
measure: Incidence of major cardiovascular and cerebrovascular adverse events
timeFrame: 1 day of discharge, 30 days, 1-5 year
measure: Incidence of other TAVI-related complications
timeFrame: Immediately after procedure, 1 day of discharge, 30 days, 1-5 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai NewMed Medical Co., Ltd.
Study officials:
affiliation: Principal coordinating investigator
name: Yaling Han, Professor
role: STUDY_CHAIR
affiliation: coordinating investigator
name: Mao Chen, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: coordinating investigator
name: Kai Xu, Professor
role: STUDY_DIRECTOR
References: