Venus-Vitae Pivotal Study Smart-Align Study

Aortic Valve Stenosis Clinical Trial

Official title:

Multicenter Pivotal Study to Evaluate the Treatment of Severe Aortic Valve Stenosis With Next-Generation Venus-Vitae Transcatheter Heart Valve (THV) System

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05991271
• Other study ID #: VTAR-23-03
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 31, 2023
• Est. completion date: June 30, 2029

Study information

• Verified date: August 2023
• Source: Venus MedTech (HangZhou) Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose is to evaluate the safety, effectiveness and performance of Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis.

Description:

This trial is a prospective, multi-center, non-randomized interventional study to evaluate the safety, effectiveness and performance of the Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis. Clinical visits will be scheduled at screening, pre-discharge, 30 days, 6 months, 12 months and annually thereafter to 5 years.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 30, 2029
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years

2. Patients with the symptoms of severe aortic stenosis

3. Severe aortic stenosis (AS, grade 3+), defined as AVA = 1 cm2 (AVAi = 0.6 cm2/m3) or Vmax = 4.0 m/s or MPG = 40 mmHg determined by echocardiography

4. Patients deemed for cardiac intervention by a heart team

5. Patients of all surgical risk categories can be enrolled in this study, but should follows local medical practices and regulatories.

6. Patients or their legal reprensentatives are willing to participate in the study and provide written informed consent, and agree to follow the follow-up requirements

Exclusion Criteria:

A subject meeting any of the following criteria shall be excluded:

Co-morbidities

1. Previous mechanical or biological aortic valve replacement

2. Untreated mitral, tricuspid or pulmonary valve diseases requiring procedural intervention

3. Acute myocardial infact within 30 days prior to index procedure

4. Untreated clinical significant coronary artery disease requiring revascularization

5. Any therapeutic invasive cardiac procedure performed within 30 days (or drug-eluting coronary stent/scaffold implant within 6 months)

6. Sever symptomatic carotid artery stenosis

7. Stroke or TIA within 3 months or Modified Rankin Scale = 4 disability

8. Chronic kidney disease (eGFR<30 mL/min/1.73m2)

9. Haemotologic 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 Haematooncology specialists

10. Severe right heart dysfunction Anatomical

11. LVEF < 20%

12. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation

13. Inappropriate anatomy for femoral introduction and delivery of study device

14. Native aortic valve geometry and size unfavorable for study device anchoring General

15. Haemodynamics instability requiring inotropic support or intra-aortic balloon pump (IABP) or other hemodynamic support device, or any mechanical heart assistance

16. Known hypersensitivity or contraindication to antiplatelet, antithrombotic medications, or cobalt-chromium leading to be unable to undergo index procedure per physicians' judgement

17. Life expectancy = 1 year due to noncardiac reasons

18. Active infection requiring antibiotic therapy including infective endocarditis

19. Planned relevant concomitant procedure within 30 days post index procedure

20. Pregnant, breastfeeding or intend to become pregnant within 1 year

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Device:
• Venus-Vitae Transcatheter Heart Valve System
The Venus-Vitae THV is comprised of balloon-expandable and radiopaque cobalt-chromium alloy frame, porcine pericardium tri-leaflet, porcine pericardium inner skirt, polyurethane outer skirt, PTFE assembly sutures, and three radiopaque gold markers (Figure 1). The valve utilizes Venus Endura technology and stored in a non-aqueous condition.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Venus MedTech (HangZhou) Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of deaths at the one-year follow-up visit post procedure	All-cause mortality (The rate of deaths at the one-year follow-up visit post procedure)	1 Years
Primary	Acceptable Hemodynamic Performance at 30 days	Acceptable Bio-prosthesis Hemodynamic Performance at 30 days, defined as: Mean gradient < 20mmHg; Less than moderate aortic regurgitation (perivalvular and transvalvular)	30 Days
Secondary	Occurrence of the following adverse events echocardiogram during follow-up	Occurrence of the following adverse events echocardiogram during follow-up (The rate of follow events during the follow-up); All-cause mortality; All stroke; Life-threatening bleeding; Acute MI; Heart failure hospitalizations; New permanent pacemaker implantation; Major vascular complication; Acute kidney injury; Aortic valve re-intervention (surgical or transcatheter); Valve thrombosis; Structural valve deterioration	5 Years
Secondary	Technical success is defined as the following	Technical success (at exit from procedure room) (VARC-3[1]) (The rate of Technical success at the Procedure); Freedom from mortality; Successful access, delivery of the device, and retrieval of the delivery system; Correct positioning of a single prosthetic heart valve into the proper anatomical location; Freedom from surgery or intervention related to the device or a major vascular or access-related, or cardiac structural complication	During the Procedure
Secondary	The rate of device success is defined as the following	Device success (in-hospital) (VARC-3[1]) (The rate of device success during the in-hospital); Freedom from mortality; Freedom from surgery or intervention related to the device or a major vascular or access-related or cardiac structural complication; Intended performance of the valve (mean gradient < 20 mmHg, peak velocity <3 m/s, and less than moderate aortic regurgitation)	Up to 1 week
Secondary	The rate of acceptable valve function at pre-discharge by echocardiogram defined as the following:	Acceptable valve function at pre-discharge by echocardiogram (The rate of follow events during the follow-up); Freedom from moderate or greater patient-prosthesis mismatch (PPM); MPG <20mmHg; Freedom from moderate or greater regurgitation (transvalvular and paravalvular); Freedom from reoperation or intervention	Up to 1 week
Secondary	The rate of freedom from severe coronary overlap assessed by post-implant angiogram	Freedom from severe coronary overlap assessed by post-implant angiogram	immediately after the procedure
Secondary	The rate of freedom from mild or greater commissure misalignment assessed by post-implant angiogram and/or 30-day CT	Freedom from mild or greater commissure misalignment assessed by post-implant angiogram and/or 30-day CT (post-implant 30-day CT scan is not mandatory for each subjects)	30-Days
Secondary	The rate of freedom from mild or greater PVL by echocardiogram during follow-up	Freedom from mild or greater PVL by echocardiogram during follow-up	5 Years
Secondary	New York Heart Association (NYHA) classification during follow-up	New York Heart Association (NYHA) classification during follow-up	5 Years