Venus-Vitae Pivotal Study Smart-Align Study

Official title

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

Overview

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

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.

Interventions

• 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.

Primary outcome measures

• The rate of deaths at the one-year follow-up visit post procedure [Time frame: 1 Years]
• Acceptable Hemodynamic Performance at 30 days [Time frame: 30 Days]

Secondary outcome measures (8)

• Occurrence of the following adverse events echocardiogram during follow-up [Time frame: 5 Years]
• Technical success is defined as the following [Time frame: During the Procedure]
• The rate of device success is defined as the following [Time frame: Up to 1 week]
• The rate of acceptable valve function at pre-discharge by echocardiogram defined as the following: [Time frame: Up to 1 week]
• The rate of freedom from severe coronary overlap assessed by post-implant angiogram [Time frame: immediately after the procedure]
• The rate of freedom from mild or greater commissure misalignment assessed by post-implant angiogram and/or 30-day CT [Time frame: 30-Days]
• The rate of freedom from mild or greater PVL by echocardiogram during follow-up [Time frame: 5 Years]
• New York Heart Association (NYHA) classification during follow-up [Time frame: 5 Years]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

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
• Native aortic valve geometry and size unfavorable for study device anchoring General
• Haemodynamics instability requiring inotropic support or intra-aortic balloon pump (IABP) or other hemodynamic support device, or any mechanical heart assistance
• Known hypersensitivity or contraindication to antiplatelet, antithrombotic medications, or cobalt-chromium leading to be unable to undergo index procedure per physicians' judgement
• Life expectancy ≤ 1 year due to noncardiac reasons
• Active infection requiring antibiotic therapy including infective endocarditis
• Planned relevant concomitant procedure within 30 days post index procedure
• Pregnant, breastfeeding or intend to become pregnant within 1 year

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05991271 · VTAR-23-03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗