Clinical trial NCT05652062: Prizvalve® Transcatheter Valve-in-Valve Implantation Exploratory Study
Official title: An Exploratory Study to Evaluate the Prizvalve® System in Patients With Failing Bioprosthetic Valve
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Failing Bioprosthetic Valve
Lead sponsor: Shanghai NewMed Medical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Zhongshan Hospital
First posted: 2022-12-15
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: The Prizvalve® study is a single-center, single-arm, prospective, exploratory clinical study.

Eligibility criteria: Inclusion Criteria:

1. Failing bioprosthetic valve (≥moderate stenosis and/or ≥moderate regurgitation);
2. Age≥18 years old who are not in pregnancy or lactation;
3. NYHA Function Class≥ II;
4. Patient who is anatomically suitable for the implantation of the Prizvalve® ;
5. 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 ;
6. Heart team agrees valve implantation will likely benefit the patient;
7. 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:

1. Patients with other valvular diseases that require simultaneous intervention;
2. Patients with other heart diseases that require simultaneous intervention;
3. Estimated life expectancy \< 12 months;
4. Failing valve has moderate and above paravalvular regurgitation;
5. Failing valve in unstable ore not structurally intact;
6. Increased risk of coronary artery obstruction by prosthetic leaflets of the failing valve;
7. Anatomical characteristics that would preclude transcatheter valve implantation;
8. Anatomical characteristics that would increase the risk of left ventricular outflow tract (LVOT) obstruction;
9. Patient with acute myocardial infarction within 30 days;
10. Any therapeutic cardiac operation (excluding previous PCI and pacemaker implantation) is performed within 30 days of the index procedure;
11. Patient with hypertrophic cardiomyopathy with obstruction;
12. Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
13. Patients with active infective endocarditis or other active infections;
14. Patients with severe right ventricular dysfunction, or severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) \< 20%;
15. Patients who cannot tolerate anticoagulant or antiplatelet therapy;
16. Patients with severe untreated coronary artery stenosis requiring revascularization;
17. Patients with cerebrovascular accident within 3 months, excluding transient ischemic attack;
18. Patients who refuse surgical treatment in emergency situations under any circumstances;
19. Patients who have severely disabled Alzheimer's disease and inability to take care of themselves;
20. 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;
21. The investigator judged that patient with poor compliance and could not complete the study as required.

Primary outcomes:
measure: Composite of all-cause mortality and valve-related reintervention
timeFrame: 1 year
Secondary outcomes:
measure: Technical success
timeFrame: 30 days
measure: Procedural Success
timeFrame: 30 days
measure: Device success
timeFrame: 30 days
measure: All-cause mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
Study officials:
References: