Aortic Valve Disease, Cardiovascular Diseases
Conditions
Keywords
Heart Failure, Surgical Cardiovascular Devices
Brief 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.
Detailed description
This is a prospective, multicenter, non-randomized interventional study to evaluate the safety, effectiveness, and performance of Venus-Neo Surgical Aortic Valve. 155 subjects are estimated to be enrolled in this study. Total enrollment period for this trial is estimated to be 1 year. Follow-up duration is estimated to be 5 years. Overall duration of the trial is estimated to be 6 years. The trial begins with the enrollment of the first subject and ends after the last subject is exited from the trial after completing the last follow-up visit at approximately 5 years, all subjects are fully monitored, all outstanding data queries are resolved.
Interventions
DEVICEVenus-Neo Surgical Aortic Valve
Implant of a Venus-Neo Surgical Aortic Valve
Sponsors
Jilin Venus Haoyue Medtech Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| secondary composite safety endpoint | 2 through 5 Years | safety is assessed over 1-year timeframe by comparing the occurrence of specific safety endpoints to the objective performance criteria (OPC) reported in Table I.1 in ISO:5840-2:2021(E), Annex I, Methods of evaluating clinical data against objective performance criteria |
| Occurrence of each of the following adverse events | baseline, pre-discharge, 30 days, 6 months, 12 months and annually until 5 years thereafter | Occurrence of each of the following adverse events until 5 years, including: mortality, valve-related mortality, thromboembolism, aortic valve reintervention, structural valve deterioration, non-structural valve deterioration, all paravalvular leak, major paravalvular leak, valve thrombosis, endocarditis, all hemorrhage, major hemorrhage, bioprosthetic valve explant, hemolysis |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinically acceptable bioprosthetic valve performance | baseline, pre-discharge, 30 days, 6 months, 12 months and annually until 5 years thereafter | Clinically acceptable bioprosthetic valve performance until 5 years: clinically acceptable effective orifice area (EOA), mean pressure gradient (MPG) \<20mmHg, freedom from moderate or greater regurgitation (transvalvular and paravalvular), freedom from aortic valve reintervention, freedom from clinically significant bioprosthetic valve thrombosis |
| Procedure success | pre-discharge | Procedure success at pre-discharge: freedom from valve-related mortality, freedom from aortic valve reintervention, intended performance of bioprosthetic valve (mean gradient \<20 mmHg, peak velocity \<3 m/s, and less than moderate aortic regurgitation) |
| New York Heart Association (NYHA) classification | baseline, pre-discharge, 30 days, 6 months, 12 months and annually until 5 years thereafter | New York Heart Association (NYHA) classification until 5 years |
Countries
Germany
Contacts
Primary ContactDestino
Outcome results
None listed