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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Diseases; Aortic Valve Disease
• Intervention / Treatment: Device: Venus-Neo Surgical Aortic Valve

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 Type: Interventional
• Enrollment (Estimated): 155
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Destino; Phone Number: +493045932260; Email: nadia.destino@dhzc-charite.de

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Deutsches Herzzentrum Berlin-Charité
    • Principal Investigator: Volkmar Falk
    • Contact: Destino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Jilin Venus Haoyue Medtech Limited
• Investigators: Principal Investigator: Volkmar Falk, Deutsches Herzzentrum Berlin-Charité

Study record dates

Study Major Dates

• Study Start (Estimated): October 31, 2023
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): October 31, 2029

Study Registration Dates

• First Submitted: July 4, 2023
• First Submitted That Met QC Criteria: July 4, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 4, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Heart Failure; Surgical Cardiovascular Devices
• Additional Relevant MeSH Terms: Heart Diseases; Heart Valve Diseases; Cardiovascular Diseases; Aortic Valve Disease
• Other Study ID Numbers: VSAF-23-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: to publish the results

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No