Venus-Vitae Pivotal Study Smart-Align Study

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: Venus-Vitae Transcatheter Heart Valve System

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

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

Description

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

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: procedure; implant valve by TAVR	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
New York Heart Association (NYHA) classification during follow-up	New York Heart Association (NYHA) classification during follow-up	5 Years

Collaborators and Investigators

• Sponsor: Venus MedTech (HangZhou) Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): October 31, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: June 26, 2023
• First Submitted That Met QC Criteria: August 10, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 14, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: VTAR-23-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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