An interventional study of transcatheter aortic valve replacement in Aortic Stenosis, Aortic Regurgitation and Heart Failure With Reduced Ejection Fraction, sponsored by Xijing Hospital. Status unknown at 1 site in China. Open to participants aged 50 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-11-13.
Sponsored by Xijing Hospital · Not applicable, Interventional, and Treatment
Transcatheter aortic valve replacement (TAVR) has a high risk and a high mortality rate in the treatment of aortic stenosis/regurgitation patients with cardiac insufficiency. The investigators aim to discuss the clinical efficacy of extracorporeal life support system(ECLS) during TAVR procedure in severe aortic lesion under very low ejection fraction (EF).
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.
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
This study's planned enrollment of 200 is above the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Xijing Hospital is the lead sponsor of 465 studies on the registry; 157 are open to participants now.
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Exclusion Criteria:
For AS/R patients with normal EF, only TAVR was performed
Procedure: transcatheter aortic valve replacement
For AS/R patients with low EF, TAVR under ECLS-assisted was performed
Procedure: transcatheter aortic valve replacement
Use Venus-A valve or J-Valve to perform TAVR procedure. Use cardiopulmonary bypass or cardiopulmonary bypass to provide ECLS
Also known as: extracorporeal life support system, extracorporeal membrane oxygenation, cardiopulmonary bypass
major adverse cardiac event
Include by limited to: death, emergency surgery, surgically related stroke, severe bleeding, rehospitalization, redo surgery
Time frame: 1 year
minor adverse event
Include by limited to: perivalvular regurgitation, infection, arrhythmia, Peripheral vascular complications
Time frame: 1 year
Plan to share: No
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This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Xijing Hospital