Cardiovascular Diseases Clinical Trial
— METASAROfficial title:
A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic Valve
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.
Status | Not yet recruiting |
Enrollment | 155 |
Est. completion date | October 31, 2029 |
Est. primary completion date | October 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Deutsches Herzzentrum Berlin-Charité | Berlin |
Lead Sponsor | Collaborator |
---|---|
Jilin Venus Haoyue Medtech Limited |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Clinically acceptable bioprosthetic valve performance | 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 | baseline, pre-discharge, 30 days, 6 months, 12 months and annually until 5 years thereafter | |
Other | Procedure success | 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) | pre-discharge | |
Other | New York Heart Association (NYHA) classification | New York Heart Association (NYHA) classification until 5 years | baseline, pre-discharge, 30 days, 6 months, 12 months and annually until 5 years thereafter | |
Primary | primary composite safety endpoint | 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 | 1 year | |
Secondary | secondary composite safety endpoint | 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" | 2 through 5 Years | |
Secondary | Occurrence of each of the following adverse events | 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 | baseline, pre-discharge, 30 days, 6 months, 12 months and annually until 5 years thereafter |
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