Transcatheter Aortic Valve Replacement With Extracorporeal Life System Support
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Aortic Regurgitation
- Aortic Stenosis
- Heart Failure With Reduced Ejection Fraction
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: ECLS-assisted TAVR for patients with very low EF(<20%). Only TAVR for patients with fair EF(>20%)Masking: Single (Participant)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 50 years and 99 years
- Gender
- Both males and females
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 a...
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.
Tracking Information
- NCT #
- NCT04160624
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Shiqiang Yu, M.D. PH.D. Xijing Hospital, Air Force Military Medical University
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