Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) in the Chinese Population
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03466918|
Recruitment Status : Active, not recruiting
First Posted : March 15, 2018
Results First Posted : July 15, 2020
Last Update Posted : September 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Aortic Stenosis Symptomatic Aortic Stenosis Aortic Regurgitation||Device: SAPIEN 3 THV with the Commander delivery system||Not Applicable|
Edwards SAPIEN 3 Transcatheter Heart Valve and Commander delivery system will be used for this study.
A maximum of 60 patients with symptomatic severe calcific aortic stenosis requiring transcatheter aortic valve implantation (TAVI), who are considered high risk for surgical valve replacement who received a SAPIEN 3 THV.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) in the Chinese Population|
|Actual Study Start Date :||May 23, 2018|
|Actual Primary Completion Date :||July 3, 2019|
|Estimated Study Completion Date :||September 2023|
Experimental: Patients with SAPIEN 3 THV
Patients will be treated with Edwards SAPIEN 3 Transcatheter Heart Valve and Commander delivery system
Device: SAPIEN 3 THV with the Commander delivery system
Edwards SAPIEN 3 Transcatheter Heart Valve is implanted using the Commander delivery system
- All-cause Mortality [ Time Frame: 30-days ]All of the deaths that occurred in this population regardless of the cause.
- Cardiovascular Mortality [ Time Frame: 30-days ]All of the deaths that occurred in this population due to a cardiovascular issue.
- Non-Cardiovascular Mortality [ Time Frame: 30-days ]All of the deaths that occurred in this population due to a non-cardiovascular issue.
- Number of Participants With a Stroke [ Time Frame: 30-days ]Total number of participates with a stroke.
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): NCT03466918
|Fuwai Hospital, CAMS&PUMC|
|WestChina Hospital, Sichuan University|
|The Second Affiliated Hospital of Zhejiang University School of Medicine|
|Zhongshan Hospital Fudan University|
|Principal Investigator:||Prof Junbo GE||Zhongshan Hospital and Fudan University|