N/A
Completed N=1,057
THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial
Critical Aortic Stenosis
Source: ClinicalTrials.gov NCT00530894 ↗
Enrolled (actual)
1,057
Serious AEs
71.1%
Results posted
May 2017
Primary outcomePrimary: Death — 84; 89; 55; 89 participants
Summary
The purpose of this study is to determine the safety and effectiveness of the device and delivery systems (transfemoral and transapical) in high risk, symptomatic patients with severe aortic stenosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Death |
84; 89; 55; 89 | — |
| PRIMARY Composite of Death and Recurrence Hospitalization. |
76; 126 | — |
| SECONDARY Functional Change of NYHA |
2.50; 2.60; 2.88; 3.92 | — |
| SECONDARY Number of Participants With Major Adverse Cardiac and Cerebro-vascular Events (MACCE) |
93; 97; 61; 93 | — |
| SECONDARY Total Hospital Days From the Index Procedure |
17.42; 20.14; 25.24; 17.04 | — |
| SECONDARY Change in Quality of Life (QOL) From Baseline to 1 Year |
70.0; 71.1; 69.41; 46.98; 36.3; 36.9 | — |
Eligibility Criteria
Inclusion Criteria Cohort A
- Patients must have co-morbidities such that the surgeon and cardiologist Co-PIs concur that the predicted risk of operative mortality is ≥15% and/or a minimum STS score of 10
- Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s or an initial aortic valve area of 3+).
- Any therapeutic invasive cardiac procedure performed within 30 days of the index procedure, (or 6 months if the procedure was a drug eluting coronary stent implantation).
- Pre-existing prosthetic heart valve in any position, prosthetic ring, or severe (greater than 3+) mitral insufficiency.
Data sourced from ClinicalTrials.gov (NCT00530894). 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.