A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic Valve

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic Valve

Conditions
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Aortic Valve Disease, Cardiovascular Diseases

Intervention / Treatment
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* Device: Venus-Neo Surgical Aortic Valve


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Patients who are clinically indicated for aortic valve replacement Patients who are willing and able to participate in the follow-up requirements, and provide written informed consent Exclusion Criteria: Previous surgical or/and transcatheter cardiac valve replacement at any site Previous open-heart surgical valve repair at any site Any percutaneous cardiovascular intervention (excluding diagnostic percutaneous coronary artery intervention), cardiovascular surgery, carotid surgery within 30 days Untreated mitral, tricuspid, or pulmonary valve diseases requiring procedural intervention Untreated clinically significant coronary artery diseases requiring revascularization Acute myocardial infarct within the previous 30 days Severe right heart dysfunction Active infection requiring antibiotic therapy including infective endocarditis Hypertrophic obstructive cardiomyopathy (HOCM) Severe symptomatic carotid artery stenosis Stroke or TIA within 3 months or Modified Rankin Scale ≥ 4 disability Chronic kidney disease (eGFR<45 mL/min/1.73m2) or end-stage renal disease requiring chronic dialysis 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 Severe chronic lung disease Previous organ transplant or currently an organ transplant candidate Anatomical LVEF < 20% Left ventricular end diastolic diameter (LVEDD) >70mm Echocardiographic evidence of intracardiac mass, thrombus, or vegetation Native aortic valve geometry and size unfavorable for study bioprosthetic valve General Hemodynamics instability requiring inotropic support or intra-aortic balloon pump (IABP) or other hemodynamic support device, or any mechanical heart assistance Urgent, emergency or salvage surgeries Known intolerance for periprocedural/post-procedural anticoagulation or antiplatelet therapy leading to be unable to undergo index procedure per physicians' judgement Life expectancy ≤ 1 year due to non-cardiac reasons Planned relevant concomitant procedure within 30 days post index procedure Current or recent participation (within 6 weeks prior to index procedure) in another drug or device trial Pregnant, breastfeeding or intend to become pregnant within 1 year Currently incarcerated or unable to give voluntary informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Venus-Neo group<br>Procedure: surgical aortic valve replacement | Device: Venus-Neo Surgical Aortic Valve<br>* Implant of a Venus-Neo Surgical Aortic Valve<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Surgical Cardiovascular Devices