Venus-Vitae Pivotal Study Smart-Align Study

NCT05991271 | Not Yet Recruiting

• 1 other identifier: VTAR-23-03
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Occurrence of the following adverse events echocardiogram during follow-up

  5 Years

• Technical success is defined as the following

  During the Procedure

• The rate of device success is defined as the following

  Up to 1 week

• The rate of acceptable valve function at pre-discharge by echocardiogram defined as the following:

  Up to 1 week

• The rate of freedom from severe coronary overlap assessed by post-implant angiogram

  immediately after the procedure

Study Arms (1)

procedure

EXPERIMENTAL

implant valve by TAVR

Device: Venus-Vitae Transcatheter Heart Valve System

Interventions

Venus-Vitae Transcatheter Heart Valve System DEVICE

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.

procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Patients with the symptoms of severe aortic stenosis
• 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
• Patients deemed for cardiac intervention by a heart team
• Patients of all surgical risk categories can be enrolled in this study, but should follows local medical practices and regulatories.
• 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

You may not qualify if:

• A subject meeting any of the following criteria shall be excluded:
• Co-morbidities
• Previous mechanical or biological aortic valve replacement
• Untreated mitral, tricuspid or pulmonary valve diseases requiring procedural intervention
• Acute myocardial infact within 30 days prior to index procedure
• Untreated clinical significant coronary artery disease requiring revascularization
• Any therapeutic invasive cardiac procedure performed within 30 days (or drug-eluting coronary stent/scaffold implant within 6 months)
• Sever symptomatic carotid artery stenosis
• Stroke or TIA within 3 months or Modified Rankin Scale ≥ 4 disability
• Chronic kidney disease (eGFR\<30 mL/min/1.73m2)
• 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
• Severe right heart dysfunction Anatomical
• LVEF \< 20%
• Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
• Inappropriate anatomy for femoral introduction and delivery of study device

Sponsors & Collaborators

• Venus MedTech (HangZhou) Inc.: lead

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: August 14, 2023
• Study Start: October 31, 2023
• Primary Completion: December 31, 2024
• Study Completion (Estimated): June 30, 2029
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share