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Tests treatment safety and results for Aortic Valve Stenosis
Official title To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Stenosis
ClinicalTrials.gov ID: NCT04893603
What this study is testing
- What it's testing
- To Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System ( Chengdu Silara Medtech Inc. ,Chengdu, China)in Patients with Severe Aortic Stenosis with or without Moderate or Lower Degree Regurgitation
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 70 and older
You may be able to join if
- Age ≥70 years old;
- Symptomatic severe aortic stenosis determined by echocardiogram, defined as: mean gradient ≥40 mmHg or peak jet velocity ≥4.0 m/s, or an aortic valve...
- NYHA Functional Class ≥II;
- Life expectancy after aortic valve implantation thought to be \>1 year;
- Native valvular or peripheral vascular anatomy is appropriate for TAVR;
You likely can't join if
- Anatomy is not appropriate for percutaneous valve implantation. Native valve annulus diameter is not in the scope of application(native TAV diameter...
- Evidence of an acute myocardial infarction within 30 days prior to the study procedure, defined as: Q-wave myocardial infarction, or non-Q-wave...
- Any treatment for traumatic cardiac surgery within 30 day prior to the study procedure(except coronary revascularization);
- Pre-existing prosthetic valve in any position(except severely dysfunctional aortic bioprosthesis), or severe (\>3+) mitral insufficiency, or Gorlin...
- Hematological abnormality, defined as: Leukopenia (WBC \<3x10\^9/L), acute anemia (Hb \<90g/L), or thrombocytopenia (platelet...
- Hemodynamic unstable requiring myocardial contractile support or mechanical cardiac assistance;
See the full eligibility criteria
- Age ≥70 years old;
- Symptomatic severe aortic stenosis determined by echocardiogram, defined as: mean gradient ≥40 mmHg or peak jet velocity ≥4.0 m/s, or an aortic valve area \<0.8 cm2 or aortic valve area index \<0.5 cm2/m2.
- NYHA Functional Class ≥II;
- Life expectancy after aortic valve implantation thought to be \>1 year;
- Native valvular or peripheral vascular anatomy is appropriate for TAVR;
- Patient is assessed by at least two cardiothoracic surgeons and recorded as not suitable for surgery;
- Patient can understand the purpose of the study, voluntarily participates and signs the informed consent form and is willing to accept the relevant examination and clinical follow-up visits.
- Anatomy is not appropriate for percutaneous valve implantation. Native valve annulus diameter is not in the scope of application(native TAV diameter ≤21mm, or ≥30mm);
- Evidence of an acute myocardial infarction within 30 days prior to the study procedure, defined as: Q-wave myocardial infarction, or non-Q-wave myocardial infarction, with CK-MB≥2 ULN/or elevated TN (WHO definition);
- Any treatment for traumatic cardiac surgery within 30 day prior to the study procedure(except coronary revascularization);
- Pre-existing prosthetic valve in any position(except severely dysfunctional aortic bioprosthesis), or severe (\>3+) mitral insufficiency, or Gorlin syndrome;
- Hematological abnormality, defined as: Leukopenia (WBC \<3x10\^9/L), acute anemia (Hb \<90g/L), or thrombocytopenia (platelet count\<50×109/L),history of bleeding diathesis or coagulopathy;
- Hemodynamic unstable requiring myocardial contractile support or mechanical cardiac assistance;
- Severe ventricular insufficiency. Left ventricular ejection fraction (LVEF) \<20%;
- Echocardiographic evidence of intra-cardiac thrombus or vegetation etc.;
- Active pepticulcer or upper GI bleeding within 3 months prior to the study procedure;
- Cerebral Vascular Accident (CVA) within 3 months prior to the study procedure, including TIA;
- A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, or sensitivity to contrast media, which cannot be adequately pre-medicated;
- Patients with infective endocarditis or other active stage of infection;
- Currently participating in an investigational drug or another device trial.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 70 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.