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

Aortic Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03314857
• Other study ID #: 2015 06
• Status: Completed
• Phase: N/A
• Start date: September 18, 2017
• Est. completion date: June 15, 2023

Study information

• Verified date: August 2023
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: June 15, 2023
• Est. primary completion date: July 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. 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.

3. NYHA Functional Class II or greater.

4. 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.

5. The study patient agrees to comply with all required post procedure follow-up visits.

Exclusion Criteria:

1. Evidence of an acute myocardial infarction = 1 month (30 days) before the intended treatment.

2. Aortic valve is a congenital unicuspid or is non-calcified.

3. 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).

4. Anomalous coronary artery that would interfere with proper placement of the valve.

5. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).

Related Conditions & MeSH terms

• Aortic Regurgitation
• Aortic Stenosis
• Aortic Valve Insufficiency
• Aortic Valve Stenosis
• Constriction, Pathologic
• Symptomatic Aortic Stenosis

Intervention

Device:
• SAPIEN XT THV with the NovaFlex+ delivery system
Edwards SAPIEN XT™ Transcatheter Heart Valve along with NovaFlex+ delivery system

Locations

Country	Name	City	State
China	Fuwai Hospital, CAMS&PUMC	Beijing
China	The Second Affiliated Hospital of Zhejiang University School of	Hangzhou
China	WestChina Hospital, Sichuan University	Sichuan	Chengdu

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause Mortality	All of the deaths that occurred in this population regardless of the cause.	30 days
Secondary	Cardiovascular Mortality	All of the deaths that occurred in this population due to a cardiovascular issue.	30 days
Secondary	Number of Participates With a Stroke	Total number of participates with a stroke.	30 days