Evaluating the SAPIEN 3 Heart Valve System for Aortic Stenosis

SAPIEN 3 China Post Market Registry Study

This study is testing how safe and effective the SAPIEN 3 heart valve is for people with severe aortic stenosis who are getting a specific heart procedure called TAVR.

Quick facts

• Study type: Observational
• Enrollment: 250 (estimated)
• Sex: All
• Sponsor: Edwards Lifesciences (Industry-sponsored)
• Locations: 14 sites (Beijing, Beijing and 13 other locations)
• Trial ID: NCT05168826 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the long-term safety and effectiveness of the SAPIEN 3 Transcatheter Heart Valve system in patients with severe aortic stenosis. It involves a single-arm, multicenter approach where participants will undergo transcatheter aortic valve replacement (TAVR) as part of their standard care. The study will collect real-world data to better understand outcomes associated with this treatment. The heart team at each site will determine patient eligibility based on specific criteria.

Who should consider this trial

Good fit: Ideal candidates are patients with symptomatic, severe, calcified aortic stenosis who are deemed appropriate for TAVR by a heart team.

Not a fit: Patients with pre-existing mechanical or bioprosthetic aortic valves or those unable to tolerate anticoagulation therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term outcomes of the SAPIEN 3 valve, potentially improving treatment strategies for patients with aortic stenosis.

How similar studies have performed: Previous studies on transcatheter aortic valve implantation have shown promising results, indicating that this approach is both effective and safe in similar patient populations.

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

Where this trial is running

Beijing, Beijing and 13 other locations

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

Study contacts

• Study coordinator: Edwards THV Clinical Affairs

Conditions Aortic Stenosis, Severe; Transcatheter aortic valve implantation; Transcatheter aortic valve replacement; SAPIEN 3; Heart disease; Cardiovascular disease