Ignite Creation Date:
2024-05-06 @ 1:55 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04160624
Status:
UNKNOWN
Last Update Posted:
2019-11-13
First Post:
2019-11-01
Brief Title:
Transcatheter Aortic Valve Replacement With Extracorporeal Life System Support
Sponsor:
Xijing Hospital
Organization:
Xijing Hospital
Study Overview
Official Title:
The Effect of Transcatheter Aortic Valve Replacement With Extracorporeal Life System Support to Cure Aortic StenosisRegurgitation Patients
Status:
UNKNOWN
Status Verified Date:
2019-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Transcatheter aortic valve replacement TAVR has a high risk and a high mortality rate in the treatment of aortic stenosisregurgitation patients with cardiac insufficiency The investigators aim to discuss the clinical efficacy of extracorporeal life support systemECLS during TAVR procedure in severe aortic lesion under very low ejection fraction EF
Detailed Description:
Transcatheter aortic valve replacement TAVR characterized by minimal invasion no need for thoracotomy and extracorporeal circulation and definite mid- and long-term efficacy has been recognized as an effective alternative replacing valve replacement through conventional thoracotomy for senile aortic valve stenosis However there are still a large number of patients whose left ventricular ejection fraction LVEF significantly declines due to the long history of disease and long-term heart injury entering the decompensation stage TAVR will still lead to such severe complications as intraoperative hemodynamic collapse and malignant arrhythmia in these patients greatly increasing the mortality rate It is pointed out in the American Heart Association Guideline 2017 that TAVR is not recommended as a treatment means for patients with very poor cardiac function under EF 20 After conservative medication the prognosis of patients with aortic valve stenosis under very low EF is poor with a 3-year mortality rate above 85 and the prognosis after heart transplantation remains controversial According to the pathological basis of patients and preoperative results of dobutamine test the cardiac systolic function of some patients is expected to be significantly improved after removal of aortic valve stenosis Therefore applying extracorporeal life support system such as extracorporeal membrane oxygenation ECMO or cardiopulmonary bypass CPB in the guarantee of cardiopulmonary function during perioperative period of TAVR is considered as the optimal surgical strategy for such patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None