Venus-Vitae Pivotal Study Smart-Align Study
ConditionAortic Valve Stenosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVenus MedTech (HangZhou) Inc.
About this trial
The purpose is to evaluate the safety, effectiveness and performance of Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Venus-Vitae Transcatheter Heart Valve System
Treatment groups
150 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov