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Transcatheter Aortic Valve Replacement With Extracorporeal Life System Support

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04160624
Recruitment Status : Recruiting
First Posted : November 13, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Jian Yang, Xijing Hospital

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Aortic Stenosis Aortic Regurgitation Heart Failure With Reduced Ejection Fraction Procedure: transcatheter aortic valve replacement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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
Official Title: The Effect of Transcatheter Aortic Valve Replacement With Extracorporeal Life System Support to Cure Aortic Stenosis/Regurgitation Patients
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. major adverse cardiac event [ Time Frame: 1 year ]
    Include by limited to: death, emergency surgery, surgically related stroke, severe bleeding, rehospitalization, redo surgery


Secondary Outcome Measures :
  1. minor adverse event [ Time Frame: 1 year ]
    Include by limited to: perivalvular regurgitation, infection, arrhythmia, Peripheral vascular complications



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Ages Eligible for Study:   50 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04160624


Contacts
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Contact: Jian Yang, M.D PH.D +8613892828016 yangjian@fmmu.edu.cn
Contact: Jiayou Tang, M.D PH.D +8615353618121 tjy-heart@outlook.com

Locations
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China, Shaanxi
Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical University Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Jian Yang, M.D. Ph.D.    +8613892828016    yangjian@fmmu.edu.cn   
Contact: Jiayou Tang, M.D. Ph.D.    +8615353618121    tjy-heart@outlook.com   
Sponsors and Collaborators
Xijing Hospital
Investigators
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Principal Investigator: Shiqiang Yu, M.D. PH.D. Xijing Hospital, Air Force Military Medical University

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Responsible Party: Jian Yang, Deputy chief surgeon, Xijing Hospital
ClinicalTrials.gov Identifier: NCT04160624    
Other Study ID Numbers: xjyyxwk002
First Posted: November 13, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Valve Insufficiency
Constriction, Pathologic
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Heart Valve Diseases
Ventricular Outflow Obstruction