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

Not Applicable

Completed

• Conditions: Symptomatic Aortic Stenosis; Aortic Regurgitation; Aortic Stenosis
• Interventions: Device: SAPIEN XT THV with the NovaFlex+ delivery system

• Registration Number: NCT03314857
• Lead Sponsor: Edwards Lifesciences

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.

Study Timeline

• Study Start: 2017-09-18
• Study First Submitted: 2017-10-16
• Study First Submitted QC: 2017-10-16
• Study First Posted: 2017-10-19
• Primary Completion: 2018-07-06
• Results First Submitted: 2020-06-29
• Results First Submitted QC: 2020-06-29
• Results First Posted: 2020-07-15
• Study Completion: 2023-06-15
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-23
• Last Update Posted: 2023-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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+).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with SAPIEN XT THV	SAPIEN XT THV with the NovaFlex+ delivery system	Patients will be treated with Edwards SAPIEN XT™ Transcatheter Heart Valve and NovaFlex+ delivery system

Primary Outcome Measures

Name	Time	Method
All-cause Mortality	30 days	All of the deaths that occurred in this population regardless of the cause.

Secondary Outcome Measures

Name	Time	Method
Cardiovascular Mortality	30 days	All of the deaths that occurred in this population due to a cardiovascular issue.
Number of Participates With a Stroke	30 days	Total number of participates with a stroke.

Trial Locations

Locations (3)

Fuwai Hospital, CAMS&PUMC; 🇨🇳 Beijing, China

The Second Affiliated Hospital of Zhejiang University School of; 🇨🇳 Hangzhou, China

WestChina Hospital, Sichuan University; 🇨🇳 Sichuan, Chengdu, China