N/A
Completed N=583
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7
Symptomatic Severe Aortic Stenosis
Source: ClinicalTrials.gov NCT03222141 ↗
Enrolled (actual)
583
Serious AEs
39.8%
Results posted
Aug 2018
Primary outcomePrimary: The Composite Rate of All-cause Mortality, All Stroke, and AI ≥ Moderate — 6.7 percentage of patients
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, severe aortic stenosis, and are in high risk.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Composite Rate of All-cause Mortality, All Stroke, and AI ≥ Moderate |
6.7 | — |
| SECONDARY Number of Participants With Major Vascular Complications |
29 | — |
| SECONDARY Number of Participants With Aortic Insufficiency at 30 Days |
16 | — |
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 ≤0.8 cm2 or indexed EOA 8
Exclusion Criteria
- Pre-existing mechanical or bioprosthetic valve in any position.
- Active bacterial endocarditis within 6 months (180 days) of procedure.
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
- Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure. Implantation of a permanent pacemaker or ICD is not considered exclusion criteria.
- Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
Data sourced from ClinicalTrials.gov (NCT03222141). 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. Informational only — not medical advice.