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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Venus-Vitae Transcatheter Heart Valve System
DeviceThe 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.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: procedureExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
1 Years2
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)
Time frame
30 DaysSecondary outcomes
1
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
Time frame
5 Years2
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
Time frame
During the Procedure3
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)
Time frame
Up to 1 week4
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
Time frame
Up to 1 weekLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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