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

Cardiovascular Diseases Clinical Trial

— METASAR  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05941455
• Other study ID #: VSAF-23-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 31, 2023
• Est. completion date: October 31, 2029

Study information

• Verified date: July 2023
• Source: Jilin Venus Haoyue Medtech Limited
• Contact: Destino
• Phone: +493045932260
• Email: nadia.destino[@]dhzc-charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Aortic Valve Disease
• Cardiovascular Diseases

Intervention

Device:
• Venus-Neo Surgical Aortic Valve
Implant of a Venus-Neo Surgical Aortic Valve

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum Berlin-Charité	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Jilin Venus Haoyue Medtech Limited

Country where clinical trial is conducted

Germany, 

Outcome

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