N/A
Completed N=2,032
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk
Symptomatic Severe Aortic Stenosis
Source: ClinicalTrials.gov NCT01314313 ↗
Enrolled (actual)
2,032
Serious AEs
70.1%
Results posted
Aug 2018
Primary outcomePrimary: All-cause Death or Disabling Stroke to Two Years — 192; 202 Participants
Summary
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All-cause Death or Disabling Stroke to Two Years |
192; 202 | — |
| SECONDARY Adjusted Days Alive and Out of Hospital (DAOH) to Two Years |
629.4; 597.8 | — |
| SECONDARY Total Aortic Regurgitation (AR) at 2 Years |
1.2; 0.5 | — |
| SECONDARY 6MWT Change From Baseline |
14.5; NA | — |
| SECONDARY NYHA Classification at 2 Years |
1.5; 1.4 | — |
| SECONDARY Effective Orifice Area (EOA) |
1.5; 1.4 | — |
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 3+).
- Preexisting mechanical or bioprosthetic valve in any position (except NR3).
- Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker or ICD (S3 Cohort only) is not excluded.
- Heart team assessment of inoperability (including examining cardiac surgeon).
Data sourced from ClinicalTrials.gov (NCT01314313). 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.