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

NCT ID: NCT05941455

Last Updated: 2023-07-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2029-10-31

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.

Conditions

Aortic Valve Disease; Cardiovascular Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Venus-Neo group

Procedure: surgical aortic valve replacement

Group Type: EXPERIMENTAL

Venus-Neo Surgical Aortic Valve

Intervention Type: DEVICE

Implant of a Venus-Neo Surgical Aortic Valve

Interventions

Venus-Neo Surgical Aortic Valve

Implant of a Venus-Neo Surgical Aortic Valve

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jilin Venus Haoyue Medtech Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Volkmar Falk

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum Berlin-Charité

Locations

Deutsches Herzzentrum Berlin-Charité

Berlin, , Germany

Countries

Germany

Central Contacts

Destino

Role: CONTACT

nadia.destino@dhzc-charite.de

+493045932260

Facility Contacts

Destino

Role: primary

Other Identifiers

VSAF-23-02

Identifier Type: -

Identifier Source: org_study_id