N/A
N=58
China S3: Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 THV in the Chinese Population
Aortic Stenosis · Symptomatic Aortic Stenosis · Aortic Regurgitation
Bottom Line
View on ClinicalTrials.gov: NCT03466918 ↗Enrolled (actual)
58
Serious AEs
26.0%
Results posted
Jul 2020
Primary outcome: Primary: All-cause Mortality — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SAPIEN 3 THV with the Commander delivery system (Device)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Edwards Lifesciences
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All-cause Mortality |
— | — |
| SECONDARY Cardiovascular Mortality |
— | — |
| SECONDARY Non-Cardiovascular Mortality |
— | — |
| SECONDARY Number of Participants With a Stroke |
1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
- 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 40mmHg, or peak aortic jet velocity > 4.0m/sec.
- NYHA Functional Class II or greater.
- 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.
- The study patient agrees to comply with all required postprocedure follow-up visits.
Exclusion Criteria
- Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment.
- Aortic valve is a congenital unicuspid or is non-calcified.
- 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).
- Anomalous coronary artery that would interfere with proper placement of the valve.
- Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).
Data sourced from ClinicalTrials.gov (NCT03466918). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.