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

Edwards Lifesciences

Status: Completed

Conditions: Aortic Regurgitation; Symptomatic Aortic Stenosis; Aortic Stenosis

Treatments: Device: SAPIEN XT THV with the NovaFlex+ delivery system

Study type: Interventional

Funder types: Industry

Identifiers

NCT03314857

2015 06

Details and patient eligibility

About

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.

Full description

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

Enrollment: 67 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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+).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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67 participants in 1 patient group

Patients with SAPIEN XT THV

Experimental group

Description:

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

Treatment:

Device: SAPIEN XT THV with the NovaFlex+ delivery system