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Transcatheter Aortic Valve Replacement With Extracorporeal Life System Support

Primary Purpose

Aortic Stenosis, Aortic Regurgitation, Heart Failure With Reduced Ejection Fraction

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
transcatheter aortic valve replacement
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Stenosis

Eligibility Criteria

50 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Non-ECLS GROUP

ECLS GROUP

Arm Description

For AS/R patients with normal EF, only TAVR was performed

For AS/R patients with low EF, TAVR under ECLS-assisted was performed

Outcomes

Primary Outcome Measures

major adverse cardiac event
Include by limited to: death, emergency surgery, surgically related stroke, severe bleeding, rehospitalization, redo surgery

Secondary Outcome Measures

minor adverse event
Include by limited to: perivalvular regurgitation, infection, arrhythmia, Peripheral vascular complications

Full Information

First Posted
November 1, 2019
Last Updated
November 9, 2019
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04160624
Brief Title
Transcatheter Aortic Valve Replacement With Extracorporeal Life System Support
Official Title
The Effect of Transcatheter Aortic Valve Replacement With Extracorporeal Life System Support to Cure Aortic Stenosis/Regurgitation Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis, Aortic Regurgitation, Heart Failure With Reduced Ejection Fraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
ECLS-assisted TAVR for patients with very low EF(<20%). Only TAVR for patients with fair EF(>20%)
Masking
Participant
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-ECLS GROUP
Arm Type
Active Comparator
Arm Description
For AS/R patients with normal EF, only TAVR was performed
Arm Title
ECLS GROUP
Arm Type
Experimental
Arm Description
For AS/R patients with low EF, TAVR under ECLS-assisted was performed
Intervention Type
Procedure
Intervention Name(s)
transcatheter aortic valve replacement
Other Intervention Name(s)
extracorporeal life support system, extracorporeal membrane oxygenation, cardiopulmonary bypass
Intervention Description
Use Venus-A valve or J-Valve to perform TAVR procedure. Use cardiopulmonary bypass or cardiopulmonary bypass to provide ECLS
Primary Outcome Measure Information:
Title
major adverse cardiac event
Description
Include by limited to: death, emergency surgery, surgically related stroke, severe bleeding, rehospitalization, redo surgery
Time Frame
1 year
Secondary Outcome Measure Information:
Title
minor adverse event
Description
Include by limited to: perivalvular regurgitation, infection, arrhythmia, Peripheral vascular complications
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The age of patient is ≥50 yrs; 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). Small incision surgery of chest can be tolerated. 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: Subject who are pregnant, lactating or scheduled to pregnant during the period of the clinical new technology. Subjects with active endocarditis or rheumatic mitral valve disease. Life expectancy <1 year for cardiac or other malignant tumors. Participate in other clinical trial. In the judgment of the investigator, subjects had poor acceptance of chemotherapy, and they cannot complete the trial as required.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Yang, M.D PH.D
Phone
+8613892828016
Email
yangjian@fmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jiayou Tang, M.D PH.D
Phone
+8615353618121
Email
tjy-heart@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiqiang Yu, M.D. PH.D.
Organizational Affiliation
Xijing Hospital, Air Force Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Yang, M.D. Ph.D.
Phone
+8613892828016
Email
yangjian@fmmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Jiayou Tang, M.D. Ph.D.
Phone
+8615353618121
Email
tjy-heart@outlook.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Transcatheter Aortic Valve Replacement With Extracorporeal Life System Support

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