Patients with aortic stenosis planning to undergo transcatheter artificial aortic valve replacement
Conditions
Interventions
Case series:Before performing transcatheter artificial aortic valve replacement, the subjects used a special balloon expansion catheter to pre-expand the valve release area to optimize the aortic valv
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with severe aortic valve stenosis are not suitable for surgical aortic valve replacement when undergoing transcatheter artificial aortic valve replacement; 2. Meet the requirements for receiving transcatheter artificial aortic valve replacement; 3. Meet the requirements of pre-dilatation balloon for transcatheter artificial aortic valve replacement; 4. Expected survival at least until the end of follow-up; 5. Agree to sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Have undergone any form of aortic valve surgery; 2. Preoperative echocardiographic examination showed >=3 grade aortic insufficiency, or transesophageal ultrasound (TEE) before balloon predilation showed >=3 grade aortic insufficiency; 3. Non-valvular aortic stenosis; 4. Known congenital aortic valve abnormalities, but does not include bivalved aortic valve; 5. Cardiogenic shock, defined as systolic blood pressure continuously below 80 mmHg (without booster medication) or below 90 mmHg (with booster medication); 6. History of bacterial endocarditis within 12 months before surgery; 7. Can't take aspirin or thienopyridine; 8. Echocardiography revealed intracardiac masses, thrombi or neoplasms; 9. Any situation judged by the investigator that affects the safety or treatment outcome of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of balloon expansion catheter fixation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate surgical success rate;Rapid cardiac pacing (RVP) rate, pacing frequency and time during balloon dilatation catheter release;All-cause mortality;Incidence of nonfatal stroke;Emergency or unplanned cardiac surgery or cardiac intervention related to the use of the balloon dilatation catheter;Severe aortic valve insufficiency (4+), or increased aortic valve insufficiency grade by 2 or more;Severe vascular complications (VARC II definition);Myocardial infarction (VARC II defined standard);Angiography confirmed rupture of the annulus or aortic root caused by the expansion of the test balloon dilatation catheter;Other adverse events related to test device;Test balloon dilatation catheter size, number of attempts to release balloon dilatation catheter, and number of uses;Test balloon inflation catheter filling pressure, filling volume, test balloon inflation catheter rupture ratio;Test balloon dilatation catheter usage time (minutes), the time from the test balloon dilatation catheter entering the arterial access sheath to the withdrawal of all sheaths; | — |
Countries
China
Contacts
Public ContactChen Mao
West China Hospital, Sichuan University
Outcome results
None listed