Clinical trial NCT05168826: China S3 PMS: SAPIEN 3 China Post Market Registry Study
Official title: SAPIEN 3 China Post Market Registry Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Stenosis, Severe
Keywords: Transcatheter aortic valve implantation (TAVI)
Transcatheter aortic valve replacement (TAVR)
SAPIEN 3
Heart disease
Cardiovascular disease
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2021-12-23
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who will undergo TAVI with the Edwards SAPIEN 3 System.

Brief summary: The objective of this study is to evaluate the long term safety and effectiveness of the SAPIEN 3 Transcatheter Heart Valve system in real world setting.

Detailed description: This is an observational, single-arm, multicentre, post-market study.

Eligibility criteria: Inclusion Criteria:

1. Patient with symptomatic, severe, calcified aortic stenosis who is appropriate for the treatment with transcatheter aortic valve replacement as determined by a heart team and will undergo TAVI with the Edwards SAPIEN 3 System as part of standard-of-care treatment
2. All surgical risks as determined by the site Heart Team
3. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

1. Medical, social, or psychological conditions that preclude appropriate consent and follow-up, including subjects under guardianship
2. Considered to be part of a vulnerable population
3. Pre-existing mechanical or bioprosthetic aortic valve
4. Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
5. Cannot tolerate an anticoagulation/antiplatelet regimen
6. Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis
7. Tortuous or calcified vessels that would prevent safe entry of the dilators and sheath
8. Participating in a drug or device study that has not reached its primary endpoint

Primary outcomes:
measure: All-cause mortality
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Xiamen
country: China
facility: Xiamen Cardiovascular Hospital Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Provincial Chest Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shangahi
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiao Tong University
state: Shanxi
city: Ürümqi
country: China
facility: First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang Province
city: Ürümqi
country: China
facility: People's Hospital of Xinjiang Uygur Autonomous Region
state: Xinjiang Province
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: