Transcatheter Aortic Valve Replacement With Extracorporeal Life System Support

The Effect of Transcatheter Aortic Valve Replacement With Extracorporeal Life System Support to Cure Aortic Stenosis/Regurgitation Patients

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).

Study Overview

• Status: Unknown
• Conditions: Aortic Stenosis; Aortic Regurgitation; Heart Failure With Reduced Ejection Fraction
• Intervention / Treatment: Procedure: transcatheter aortic valve replacement

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jian Yang, M.D PH.D; Phone Number: +8613892828016; Email: yangjian@fmmu.edu.cn
• Study Contact Backup: Name: Jiayou Tang, M.D PH.D; Phone Number: +8615353618121; Email: tjy-heart@outlook.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical University
      • Contact: Jian Yang, M.D. Ph.D.; Phone Number: +8613892828016; Email: yangjian@fmmu.edu.cn
      • Contact: Jiayou Tang, M.D. Ph.D.; Phone Number: +8615353618121; Email: tjy-heart@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The age of patient is ≥50 yrs;
2. Severe aortic stenosis or regurgitation patients (The area of central regurgitation exceeds 40% of left ventricular area; regurgitant volume ≥10ml；EROA≤1.0cm2; PGmean≥50mmHg (Satisfy any condition).
3. Small incision surgery of chest can be tolerated.
4. General anesthesia is tolerable

4. The subject was informed of the clinical application nature of the technology and agreed to participate in all requirements of the clinical application of the new technology, signed the informed consent and agreed to complete.

Exclusion Criteria:

1. Subject who are pregnant, lactating or scheduled to pregnant during the period of the clinical new technology.
2. Subjects with active endocarditis or rheumatic mitral valve disease.
3. Life expectancy <1 year for cardiac or other malignant tumors.
4. Participate in other clinical trial.
5. In the judgment of the investigator, subjects had poor acceptance of chemotherapy, and they cannot complete the trial as required.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Non-ECLS GROUP; For AS/R patients with normal EF, only TAVR 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; Other Names: extracorporeal life support system; extracorporeal membrane oxygenation; cardiopulmonary bypass
Experimental: ECLS GROUP; 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; Other Names: extracorporeal life support system; extracorporeal membrane oxygenation; cardiopulmonary bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
major adverse cardiac event	Include by limited to: death, emergency surgery, surgically related stroke, severe bleeding, rehospitalization, redo surgery	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
minor adverse event	Include by limited to: perivalvular regurgitation, infection, arrhythmia, Peripheral vascular complications	1 year

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Principal Investigator: Shiqiang Yu, M.D. PH.D., Xijing hospital, Air force Military Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: November 1, 2019
• First Submitted That Met QC Criteria: November 9, 2019
• First Posted (Actual): November 13, 2019

Study Record Updates

• Last Update Posted (Actual): November 13, 2019
• Last Update Submitted That Met QC Criteria: November 9, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Valve Insufficiency; Constriction, Pathologic
• Other Study ID Numbers: xjyyxwk002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No