Status:
NOT_YET_RECRUITING
Venus-Vitae Pivotal Study Smart-Align Study
Lead Sponsor:
Venus MedTech (HangZhou) Inc.
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
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.
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2029
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05991271
Start Date
October 31 2023
End Date
June 30 2029
Last Update
August 18 2023
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.