Venus-Neo Surgical Aortic Valve: Implant of a Venus-Neo Surgical Aortic Valve
Study summary
The goal of this clinical trial is to evaluate the safety, effectiveness, and performance of Venus-Neo Surgical Aortic Valve in subjects who are clinically indicated for aortic valve replacement.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥ 18 years
2. Patients who are clinically indicated for aortic valve replacement
3. Patients who are willing and able to participate in the follow-up requirements, and provide written informed consent
Exclusion Criteria:
1. Previous surgical or/and transcatheter cardiac valve replacement at any site
2. Previous open-heart surgical valve repair at any site
3. Any percutaneous cardiovascular intervention (excluding diagnostic percutaneous coronary artery intervention), cardiovascular surgery, carotid surgery within 30 days
4. Untreated mitral, tricuspid, or pulmonary valve diseases requiring procedural intervention
5. Untreated clinically significant coronary artery diseases requiring revascularization
6. Acute myocardial infarct within the previous 30 days
7. Severe right heart dysfunction
8. Active infection requiring antibiotic therapy including infective endocarditis
9. Hypertrophic obstructive cardiomyopathy (HOCM)
10. Severe symptomatic carotid artery stenosis
11. Stroke or TIA within 3 months or Modified Rankin Scale ≥ 4 disability
12. Chronic kidney disease (eGFR\<45 mL/min/1.73m2) or end-stage renal disease requiring chronic dialysis
13. Hematologic disorders: Leukopenia (WBC \< 3000 cell/mL), anemia (Hgb \< 9 g/dL), thrombocytopenia (Plt\< 50,000 cell/mL), or any known blood clotting disorder, deemed clinically significant after consultation with Hematooncology specialists
14. Severe chronic lung disease
15. Previous organ transplant or currently an organ transplant candidate Anatomical
16. LVEF \< 20%
17. Left ventricular end diastolic diameter (LVEDD) \>70mm
18. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
19. Native aortic valve geometry and size unfavorable for study bioprosthetic valve General
20. Hemodynamics instability requiring inotropic support or intra-aortic balloon pump (IABP) or other hemodynamic support device, or any mechanical heart assistance
21. Urgent, emergency or salvage surgeries
22. Known intolerance for periprocedural/post-procedural anticoagulation or antiplatelet therapy leading to be unable to undergo index procedure per physicians' judgement
23. Life expectancy ≤ 1 year due to non-cardiac reasons
24. Planned relevant concomitant procedure within 30 days post index procedure
25. Current or recent participation (within 6 weeks prior to index procedure) in another drug or device trial
26. Pregnant, breastfeeding or intend to become pregnant within 1 year
27. Currently incarcerated or unable to give voluntary informed consent
Primary outcome measure(s)
primary composite safety endpoint — 1 year composite safety endpoint at 1 year, including: valve-related mortality, thromboembolism, aortic valve reintervention, structural valve deterioration, major paravalvular leak (defined as moderate or greater paravalvular leak or any paravalvular leak requiring intervention), valve thrombosis, endocarditis
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.