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

Not Applicable

Not yet recruiting

• Conditions: Aortic Valve Disease; Cardiovascular Diseases
• Interventions: Device: Venus-Neo Surgical Aortic Valve

• Registration Number: NCT05941455
• Lead Sponsor: Jilin Venus Haoyue Medtech Limited

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.

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-04
• Study First Submitted QC: 2023-07-04
• Last Update Submitted: 2023-07-04
• Study First Posted: 2023-07-12
• Last Update Posted: 2023-07-12
• Study Start: 2023-10-31
• Primary Completion: 2025-10-31
• Study Completion: 2029-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 155

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Venus-Neo group	Venus-Neo Surgical Aortic Valve	Procedure: surgical aortic valve replacement

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Deutsches Herzzentrum Berlin-Charité; 🇩🇪 Berlin, Germany