N/A
N=1,074
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - S3 Intermediate
Symptomatic Severe Aortic Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT03222128 ↗Enrolled (actual)
1,074
Serious AEs
55.4%
Results posted
Aug 2018
Primary outcome: Primary: Number of Participants With Composite of All-cause Death, All Stroke and Aortic Insufficiency (AI) ≥ Moderate — 125 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TAVR (Device)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Edwards Lifesciences
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Composite of All-cause Death, All Stroke and Aortic Insufficiency (AI) ≥ Moderate |
125 | — |
| SECONDARY Composite of All-cause Death, All Stroke, Life Threatening (Disabling)/ Major Bleeding and Major Vascular Complication at 30 Days |
196 | — |
Summary
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, and severe aortic stenosis, and those with intermediate risk.
Eligibility Criteria
Inclusion Criteria
- Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s and an initial aortic valve area (AVA) of 32 (in the absence of prior revascularization)
- Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of screening evaluation.
- Need for emergency surgery for any reason.
Data sourced from ClinicalTrials.gov (NCT03222128). 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.