---
title: "China S3 PMS: SAPIEN 3 China Post Market Registry Study"
nct_id: NCT05168826
overall_status: ACTIVE_NOT_RECRUITING
sponsor: Edwards Lifesciences
study_type: OBSERVATIONAL
primary_condition: Aortic Stenosis, Severe
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05168826.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05168826"
ct_last_update_post_date: 2025-07-30
last_seen_at: "2026-05-12T06:45:39.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# China S3 PMS: SAPIEN 3 China Post Market Registry Study

**Official Title:** SAPIEN 3 China Post Market Registry Study

**NCT ID:** [NCT05168826](https://clinicaltrials.gov/study/NCT05168826)

## Key Facts

- **Status:** ACTIVE_NOT_RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 250
- **Lead Sponsor:** Edwards Lifesciences
- **Conditions:** Aortic Stenosis, Severe
- **Start Date:** 2022-01-24
- **Completion Date:** 2035-12
- **CT.gov Last Update:** 2025-07-30

## 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

- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Transcatheter Aortic Valve Implantation (TAVI)**

## Interventions

- **SAPIEN 3 Transcatheter Heart Valve** (DEVICE) — Implantation of the SAPIEN 3 valve

## Primary Outcomes

- **All-cause mortality** _(time frame: 10 years)_ — The number of patients that died

## Locations (14)

- Peking University Third Hospital, Beijing, Beijing Municipality, China
- Xiamen Cardiovascular Hospital Xiamen University, Xiamen, Fujian, China
- First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
- Henan Provincial Chest Hospital, Zhengzhou, Henan, China
- The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
- Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China
- The Second Xiangya Hospital of Central South University, Changsha, Hunan, China
- Shanghai General Hospital, Shanghai, Shangahi, China
- Shanghai Chest Hospital, Shanghai, Shanghai Municipality, China
- Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai Municipality, China
- The First Affiliated Hospital of Xi'an Jiao Tong University, Xi’an, Shanxi, China
- First Affiliated Hospital of Xinjiang Medical University, Ürümqi, Xinjiang, China
- People's Hospital of Xinjiang Uygur Autonomous Region, Ürümqi, Xinjiang, China
- The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, China

## Recent Field Changes (last 30 days)

- `results.hasResults` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `locations.peking university third hospital|beijing|beijing municipality|china` — added _(2026-05-12)_
- `locations.xiamen cardiovascular hospital xiamen university|xiamen|fujian|china` — added _(2026-05-12)_
- `locations.first affiliated hospital of sun yat-sen university|guangzhou|guangdong|china` — added _(2026-05-12)_
- `locations.henan provincial chest hospital|zhengzhou|henan|china` — added _(2026-05-12)_
- `locations.the first affiliated hospital of zhengzhou university|zhengzhou|henan|china` — added _(2026-05-12)_
- `locations.union hospital affiliated to tongji medical college of huazhong university of science and technology|wuhan|hubei|china` — added _(2026-05-12)_
- `locations.the second xiangya hospital of central south university|changsha|hunan|china` — added _(2026-05-12)_
- `locations.shanghai general hospital|shanghai|shangahi|china` — added _(2026-05-12)_
- `locations.shanghai chest hospital|shanghai|shanghai municipality|china` — added _(2026-05-12)_
- `locations.xinhua hospital affiliated to shanghai jiaotong university school of medicine|shanghai|shanghai municipality|china` — added _(2026-05-12)_
- `locations.the first affiliated hospital of xi'an jiao tong university|xi’an|shanxi|china` — added _(2026-05-12)_
- `locations.first affiliated hospital of xinjiang medical university|ürümqi|xinjiang|china` — added _(2026-05-12)_
- `locations.people's hospital of xinjiang uygur autonomous region|ürümqi|xinjiang|china` — added _(2026-05-12)_
- `locations.the second affiliated hospital zhejiang university school of medicine|hangzhou|zhejiang|china` — added _(2026-05-12)_

---

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