Clinical trial NCT05991271: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aortic Valve Stenosis
Lead sponsor: Venus MedTech (HangZhou) Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Patients with the symptoms of severe aortic stenosis
3. 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
4. Patients deemed for cardiac intervention by a heart team
5. Patients of all surgical risk categories can be enrolled in this study, but should follows local medical practices and regulatories.
6. 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

1. Previous mechanical or biological aortic valve replacement
2. Untreated mitral, tricuspid or pulmonary valve diseases requiring procedural intervention
3. Acute myocardial infact within 30 days prior to index procedure
4. Untreated clinical significant coronary artery disease requiring revascularization
5. Any therapeutic invasive cardiac procedure performed within 30 days (or drug-eluting coronary stent/scaffold implant within 6 months)
6. Sever symptomatic carotid artery stenosis
7. Stroke or TIA within 3 months or Modified Rankin Scale ≥ 4 disability
8. Chronic kidney disease (eGFR\<30 mL/min/1.73m2)
9. 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
10. Severe right heart dysfunction Anatomical
11. LVEF \< 20%
12. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
13. Inappropriate anatomy for femoral introduction and delivery of study device
14. Native aortic valve geometry and size unfavorable for study device anchoring General
15. Haemodynamics instability requiring inotropic support or intra-aortic balloon pump (IABP) or other hemodynamic support device, or any mechanical heart assistance
16. Known hypersensitivity or contraindication to antiplatelet, antithrombotic medications, or cobalt-chromium leading to be unable to undergo index procedure per physicians' judgement
17. Life expectancy ≤ 1 year due to noncardiac reasons
18. Active infection requiring antibiotic therapy including infective endocarditis
19. Planned relevant concomitant procedure within 30 days post index procedure
20. Pregnant, breastfeeding or intend to become pregnant within 1 year

Primary outcomes:
measure: The rate of deaths at the one-year follow-up visit post procedure
timeFrame: 1 Years
measure: Acceptable Hemodynamic Performance at 30 days
timeFrame: 30 Days
Secondary outcomes:
measure: Occurrence of the following adverse events echocardiogram during follow-up
timeFrame: 5 Years
measure: Technical success is defined as the following
timeFrame: During the Procedure
measure: The rate of device success is defined as the following
timeFrame: Up to 1 week
measure: The rate of acceptable valve function at pre-discharge by echocardiogram defined as the following:
timeFrame: Up to 1 week
measure: The rate of freedom from severe coronary overlap assessed by post-implant angiogram
timeFrame: immediately after the procedure
measure: The rate of freedom from mild or greater commissure misalignment assessed by post-implant angiogram and/or 30-day CT
timeFrame: 30-Days
measure: The rate of freedom from mild or greater PVL by echocardiogram during follow-up
timeFrame: 5 Years
measure: New York Heart Association (NYHA) classification during follow-up
timeFrame: 5 Years
Other outcomes:
Locations:
Study officials:
References: