Clinical trial NCT05941455: A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic Valve
Official title: A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic Valve
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aortic Valve Disease
Cardiovascular Diseases
Keywords: Heart Failure
Surgical Cardiovascular Devices
Lead sponsor: Jilin Venus Haoyue Medtech Limited
Sponsor class: INDUSTRY
First posted: 2023-07-12
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: primary composite safety endpoint
timeFrame: 1 year
Secondary outcomes:
measure: secondary composite safety endpoint
timeFrame: 2 through 5 Years
measure: Occurrence of each of the following adverse events
timeFrame: baseline, pre-discharge, 30 days, 6 months, 12 months and annually until 5 years thereafter
Other outcomes:
measure: Clinically acceptable bioprosthetic valve performance
timeFrame: baseline, pre-discharge, 30 days, 6 months, 12 months and annually until 5 years thereafter
measure: Procedure success
timeFrame: pre-discharge
measure: New York Heart Association (NYHA) classification
timeFrame: baseline, pre-discharge, 30 days, 6 months, 12 months and annually until 5 years thereafter
Locations:
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin-Charité
Study officials:
affiliation: Deutsches Herzzentrum Berlin-Charité
name: Volkmar Falk
role: PRINCIPAL_INVESTIGATOR
References: