Aortic valve stenosis
Conditions
Interventions
Smart Monitoring Group:Use of CAD FLOW wearable ultrasound patch for monitoring carotid and jugular vein blood flow
clinicians make clinical decisions (e.g., valve deployment timing, fluid management, vasopressor adjustments) based on ultrasound patch data
Control Group:No neck ultrasound patch monitoring
surgical procedures, fluid management, and vasopressor adjustments based on individual clinical experience and routine indicators such as ECG, invasive arterial pressure, and echocardiography
Sponsors
The Sixth Medical Center, Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of severe aortic valve stenosis: According to the "2017 Guidelines of the American Society of Echocardiography (ASE) on Non-invasive Assessment of Valve Stenosis", any one of the following criteria is met: the area of the aortic valve orifice (EOA) is less than 1.0 cm^2; The peak velocity of the aortic valve (AV-Vmax) is >=4.0 m/s; The mean transvalvular aortic valve pressure difference (PGmean) is >=40 mmHg. 2. Patients who, after assessment, meet the indications for transcatheter aortic valve replacement (TAVR) and are scheduled to undergo TAVR.
Exclusion criteria
Exclusion criteria: 1. Patients who are unwilling to accept registration and follow-up; 2. Patients with mental illness who could not cooperate with information collection and follow-up. 3. Patients with life expectancy less than 12 months due to non-cardiac diseases (such as cancer, liver disease, kidney disease or end-stage lung disease). 4. Persistent atrial fibrillation 5. Neck skin injury, excessive subcutaneous fat or pathological conditions affecting the quality of ultrasound signals (such as carotid artery stenosis > 70%, history of carotid artery stenting).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean transvalvular pressure gradient of the aortic valve at 24-48 hours after operation.;The peak velocity of aortic valve 24-48 hours after operation.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The effective orifice area of aortic valve at 24-48 hours after operation;Cardiac ejection fraction at 24-48 hours after surgery;Incidence of perioperative complications;The treatment of the surgeon 's reference patch data and the changes of cervical arteriovenous blood flow waveforms and parameters before and after treatment were analyzed.; | — |
Countries
China
Contacts
Public ContactWang Jing
The Sixth Medical Center, Chinese PLA General Hospital
Outcome results
None listed