China S3 PMS: SAPIEN 3 China Post Market Registry Study

SAPIEN 3 China Post Market Registry Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05168826

Enrollment

250

Registered

2021-12-23

Start date

2022-01-24

Completion date

2035-12-01

Last updated

2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis, Severe

Keywords

Transcatheter aortic valve implantation (TAVI), Transcatheter aortic valve replacement (TAVR), SAPIEN 3, Heart disease, Cardiovascular disease

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.

Interventions

DEVICESAPIEN 3 Transcatheter Heart Valve

Implantation of the SAPIEN 3 valve

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
All-cause mortality	10 years	The number of patients that died

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026