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China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population

Primary Purpose

Aortic Stenosis, Symptomatic Aortic Stenosis, Aortic Regurgitation

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

SAPIEN XT THV with the NovaFlex+ delivery system

About this trial

This is an interventional treatment trial for Aortic Stenosis focused on measuring TAVI, TAVR, CHINA, SAPIEN XT, High Risk, Transcatheter aortic valve implantation, Transcatheter aortic valve replacement

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects who are considered to be operable and high risk for surgical valve replacement: 8 ≤ STS Score ≤ 15 or 15 ≤ Logistic EuroSCORE ≤ 40. If STS score is below 8 and/or Logistic EuroSCORE is below 15, patients should have other clinical or anatomical risk factors that would be considered high risk for surgery and documented by the heart team.
Severe symptomatic aortic stenosis requiring aortic valve replacement characterized by one or more of the following within 60 days prior to the index procedure: AVA < 0.8 cm2, Indexed AVA <0.5 cm2/m2, mean gradient > 40mmHg, or peak aortic jet velocity > 4.0m/sec.
NYHA Functional Class II or greater.
The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the EC of the respective clinical site.
The study patient agrees to comply with all required post procedure follow-up visits.

Exclusion Criteria:

Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment.
Aortic valve is a congenital unicuspid or is non-calcified.
Aortic valve is bicuspid and the patient is less than 60 years old, or the aortic valve is bicuspid with no raphe (Sievers classification type 0).
Anomalous coronary artery that would interfere with proper placement of the valve.
Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).

Sites / Locations

WestChina Hospital, Sichuan University
Fuwai Hospital, CAMS&PUMC
The Second Affiliated Hospital of Zhejiang University School of

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with SAPIEN XT THV

Arm Description

Patients will be treated with Edwards SAPIEN XT™ Transcatheter Heart Valve and NovaFlex+ delivery system

Outcomes

Primary Outcome Measures

All-cause Mortality

All of the deaths that occurred in this population regardless of the cause.

Secondary Outcome Measures

Cardiovascular Mortality

All of the deaths that occurred in this population due to a cardiovascular issue.

Number of Participates With a Stroke

Total number of participates with a stroke.

Full Information

NCT ID

NCT03314857

First Posted

October 16, 2017

Last Updated

August 23, 2023

Sponsor

Edwards Lifesciences

1. Study Identification

Unique Protocol Identification Number

NCT03314857

Brief Title

China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population

Official Title

Safety and Effectiveness of Edwards Lifesciences SAPIEN XT Transcatheter Heart Valve in the Chinese Population

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

September 18, 2017 (Actual)

Primary Completion Date

July 6, 2018 (Actual)

Study Completion Date

June 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Edwards Lifesciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To evaluate the safety and effectiveness of the SAPIEN XT (Edwards Lifesciences, Irvine, California) transcatheter heart valve implantation (TAVI) in Chinese patients with symptomatic severe calcific aortic stenosis who are considered at high risk for surgical valve replacement.

Detailed Description

Edwards SAPIEN XT™ Transcatheter Heart Valve and NovaFlex+ delivery system will be used for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Stenosis, Symptomatic Aortic Stenosis, Aortic Regurgitation

Keywords

TAVI, TAVR, CHINA, SAPIEN XT, High Risk, Transcatheter aortic valve implantation, Transcatheter aortic valve replacement

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

67 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients with SAPIEN XT THV

Arm Type

Experimental

Arm Description

Patients will be treated with Edwards SAPIEN XT™ Transcatheter Heart Valve and NovaFlex+ delivery system

Intervention Type

Device

Intervention Name(s)

SAPIEN XT THV with the NovaFlex+ delivery system

Intervention Description

Edwards SAPIEN XT™ Transcatheter Heart Valve along with NovaFlex+ delivery system

Primary Outcome Measure Information:

Title

All-cause Mortality

Description

All of the deaths that occurred in this population regardless of the cause.

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Cardiovascular Mortality

Description

All of the deaths that occurred in this population due to a cardiovascular issue.

Time Frame

30 days

Title

Number of Participates With a Stroke

Description

Total number of participates with a stroke.

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects who are considered to be operable and high risk for surgical valve replacement: 8 ≤ STS Score ≤ 15 or 15 ≤ Logistic EuroSCORE ≤ 40. If STS score is below 8 and/or Logistic EuroSCORE is below 15, patients should have other clinical or anatomical risk factors that would be considered high risk for surgery and documented by the heart team. Severe symptomatic aortic stenosis requiring aortic valve replacement characterized by one or more of the following within 60 days prior to the index procedure: AVA < 0.8 cm2, Indexed AVA <0.5 cm2/m2, mean gradient > 40mmHg, or peak aortic jet velocity > 4.0m/sec. NYHA Functional Class II or greater. The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the EC of the respective clinical site. The study patient agrees to comply with all required post procedure follow-up visits. Exclusion Criteria: Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment. Aortic valve is a congenital unicuspid or is non-calcified. Aortic valve is bicuspid and the patient is less than 60 years old, or the aortic valve is bicuspid with no raphe (Sievers classification type 0). Anomalous coronary artery that would interfere with proper placement of the valve. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Runlin Gao

Organizational Affiliation

Fuwai Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

WestChina Hospital, Sichuan University

City

Sichuan

State/Province

Chengdu

Country

China

Facility Name

Fuwai Hospital, CAMS&PUMC

City

Beijing

Country

China

Facility Name

The Second Affiliated Hospital of Zhejiang University School of

City

Hangzhou

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population

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