METASAR: A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic Valve
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Venus-Neo group Procedure: surgical aortic valve replacement |
Device: Venus-Neo Surgical Aortic Valve
Implant of a Venus-Neo Surgical Aortic Valve
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years
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Patients who are clinically indicated for aortic valve replacement
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Patients who are willing and able to participate in the follow-up requirements, and provide written informed consent
Exclusion Criteria:
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Previous surgical or/and transcatheter cardiac valve replacement at any site
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Previous open-heart surgical valve repair at any site
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Any percutaneous cardiovascular intervention (excluding diagnostic percutaneous coronary artery intervention), cardiovascular surgery, carotid surgery within 30 days
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Untreated mitral, tricuspid, or pulmonary valve diseases requiring procedural intervention
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Untreated clinically significant coronary artery diseases requiring revascularization
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Acute myocardial infarct within the previous 30 days
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Severe right heart dysfunction
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Active infection requiring antibiotic therapy including infective endocarditis
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Hypertrophic obstructive cardiomyopathy (HOCM)
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Severe symptomatic carotid artery stenosis
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Stroke or TIA within 3 months or Modified Rankin Scale ≥ 4 disability
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Chronic kidney disease (eGFR<45 mL/min/1.73m2) or end-stage renal disease requiring chronic dialysis
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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
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Severe chronic lung disease
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Previous organ transplant or currently an organ transplant candidate Anatomical
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LVEF < 20%
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Left ventricular end diastolic diameter (LVEDD) >70mm
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Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
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Native aortic valve geometry and size unfavorable for study bioprosthetic valve General
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Hemodynamics instability requiring inotropic support or intra-aortic balloon pump (IABP) or other hemodynamic support device, or any mechanical heart assistance
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Urgent, emergency or salvage surgeries
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Known intolerance for periprocedural/post-procedural anticoagulation or antiplatelet therapy leading to be unable to undergo index procedure per physicians' judgement
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Life expectancy ≤ 1 year due to non-cardiac reasons
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Planned relevant concomitant procedure within 30 days post index procedure
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Current or recent participation (within 6 weeks prior to index procedure) in another drug or device trial
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Pregnant, breastfeeding or intend to become pregnant within 1 year
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Currently incarcerated or unable to give voluntary informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Deutsches Herzzentrum Berlin-Charité | Berlin | Germany | 13353 |
Sponsors and Collaborators
- Jilin Venus Haoyue Medtech Limited
Investigators
- Principal Investigator: Volkmar Falk, Deutsches Herzzentrum Berlin-Charité
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VSAF-23-02