Safety and Efficacy of Emergent TAVI in Patients With Severe AS

Launched by QILU HOSPITAL OF SHANDONG UNIVERSITY · Sep 1, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of a procedure called transcatheter aortic valve implantation (TAVI) for patients with severe aortic valve stenosis (AS) who need urgent treatment. Aortic valve stenosis is a serious condition where the heart's aortic valve becomes narrowed, making it hard for blood to flow out of the heart. The study aims to gather information about how often this emergency TAVI is needed and what the outcomes are for patients who undergo it. It will help doctors better understand how to manage these complicated situations in patients who are experiencing severe symptoms.

To be part of this trial, patients must be diagnosed with severe aortic valve stenosis and face urgent medical situations, like needing CPR or having ongoing heart problems that aren't improving with regular treatment. Participants will need to give their consent and agree to follow-up examinations. It's important to note that some patients may not qualify, such as those with certain anatomical issues or severe infections. The trial is not yet recruiting participants, so it’s still in the planning stage.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Every patient that diagnosed with severe aortic valve stenosis (evaluated by echocardiography: peak transaortic valve blood flow rate ≥4.0m/s, or mean transaortic valve pressure gradient ≥40mmHg (≥5.32kPa), or aortic Valve area \<0.8cm2, or AVA\<0.5cm2/m2);
• • 2. Every patient that 1) required cardiopulmonary resuscitation due to cardiac arrest, or requiring external chest compressions during surgery (Salvage), 2) or has ongoing, refractory (difficult, complicated, and/or unmanageable) unrelenting cardiac compromise, with or without hemodynamic instability, and not responsive to any form of therapy except cardiac surgery (STS/ACC TVT defined "Urgent Status"), 3) or required urgent procedure during same hospitalization in order to minimize chance of further clinical deterioration (examples include, but are not limited to, worsening, sudden chest pain, heart failure, acute myocardial infarction, anatomy, intra-aortic balloon pump, unstable angina with intravenous nitroglycerin or rest angina) (STS/ACC TVT defined "Urgent Status");
• • 3. Every patient that has been informed of the objectives of the study, agreed to participate, has signed the approved consent form, and was willing to accept all relevant examinations and clinical follow-up.
• Exclusion Criteria:
• • 1. Anatomically, the approach or aortic root is not suitable for transcatheter aortic valve implantation (TAVI).
• • 2. Anatomical morphology or vascular diseases affecting the device approach.
• • 3. Left ventricular outflow tract obstruction.
• • 4. Primary dilated cardiomyopathy.
• • 5. The echocardiogram indicates the presence of left ventricular thrombus.
• • 6. Cannot tolerate anticoagulation and antiplatelet therapy.
• • 7. Are allergic or resistant to nickel titanium alloys.
• • 8. Active infective endocarditis, or other active infections affecting the effect of TAVI.
• • 9. Severe disabling Alzheimer's disease.
• • 10. Life expectancy\< 6 months.
• • 11. Other conditions (examples include poor compliance of patients and families) considered by the investigator to be inappropriate for participation in this clinical trial.