Clinical trial NCT03466918: China S3: Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 THV in the Chinese Population
Official title: Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) in the Chinese Population
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aortic Stenosis
Symptomatic Aortic Stenosis
Aortic Regurgitation
Keywords: TAVI
TAVR
CHINA
SAPIEN 3
High Risk
Transcatheter aortic valve implantation
Transcatheter aortic valve replacement
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2018-03-15
Enrollment: 58
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and effectiveness of the SAPIEN 3 (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 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.

Eligibility criteria: Inclusion Criteria:

1. Subjects who are considered to be operable and high risk for surgical valve replacement: STS Score ≥ 8 and ≤ 15 or Logistic EuroSCORE ≥ 15 and ≤ 40. If STS score is below 8 and 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 postprocedure 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+).

Primary outcomes:
measure: All-cause Mortality
timeFrame: 30-days
Secondary outcomes:
measure: Cardiovascular Mortality
timeFrame: 30-days
measure: Non-Cardiovascular Mortality
timeFrame: 30-days
measure: Number of Participants With a Stroke
timeFrame: 30-days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, CAMS&PUMC
city: Chengdu
country: China
facility: WestChina Hospital, Sichuan University
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
Study officials:
affiliation: Zhongshan Hospital and Fudan University
name: Prof Junbo GE
role: PRINCIPAL_INVESTIGATOR
References: