N/A
Completed N=280
EDWARDS INTUITY Elite Valve System
Source: ClinicalTrials.gov NCT02907463 ↗Enrolled (actual)
280
Serious AEs
38.6%
Results posted
Nov 2019
Primary outcomePrimary: Subject's Average Time Spent on Cardiopulmonary Cross Clamp — 49.9; 65.2; 51.9 minutes
Summary
The purpose of this active, observational, open-label, non-randomized, post-market surveillance study is to confirm that EDWARDS INTUITY Elite reduces cross clamp time (XCT) in MIS setting when compared to published data with a conventional valve within the MIS setting. The published dataset will used as a control group. Then to describe short term (30 days) and long term (6 months) clinical safety, to assess and compare hemodynamic data with EDWARDS INTUITY Elite to a conventional valve at discharge and at 6 months post AVR, to assess Quality of Life at baseline, and at 6 months post AVR to assess NYHA functional class at baseline, discharge, 1 month and at 6 months post AVR to assess Fitness for hospital discharge.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subject's Average Time Spent on Cardiopulmonary Cross Clamp |
49.9; 65.2; 51.9 | — |
| SECONDARY Subject's Average Time Spent on Cardiopulmonary Bypass. |
79.0 | — |
| SECONDARY Device Technical Success Rate |
276 | — |
| SECONDARY First Attempt Success Rate |
270 | — |
| SECONDARY Procedural Success |
274 | — |
| SECONDARY Subject's Average Health Care Utilization |
3.3; 9.5 | — |
| SECONDARY Subject's Average Mean Gradient Measurements Over Time. |
50; 46.6; 44.5; 45.3; 45.1; 46.0 | — |
| SECONDARY Subject's Average Peak Gradients Measurements Over Time. |
80.3; 78.9; 73.4; 74.8; 74.0; 76.3 | — |
| SECONDARY Subject's Average Effective Orifice Area (EOA) Measurements Over Time |
0.7; 0.8; 0.8; 0.9; 1.0; 0.8 | — |
| SECONDARY Subject's Average Effective Orifice Area Index (EOAI) Measurement Over Time. |
0.7; 0.9; 1.0; 1.0; 1.1; 0.9 | — |
| SECONDARY Subject's Average Performance Index Measurements Over Time. |
0.5; 0.5; 0.4; 0.4; 0.4; 0.5 | — |
| SECONDARY Subject's Average Cardiac Output Over Time |
4.8; 5.3; 5.4; 6.1; 6.2; 5.5 | — |
| SECONDARY Subject's Average Cardiac Index |
2.3; 2.7; 2.8; 2.8; 2.4; 2.7 | — |
| SECONDARY Subject's Amount of Paravalvular Leak Over Time. |
19; 59; 45; 45; 14; 182 | — |
| SECONDARY Subject's Amount of Aortic Valvular Regurgitation Over Time. |
15; 61; 48; 40; 14; 178 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is 18 years or older
- Subject is symptomatic for aortic stenosis (AS) or mixed aortic stenosis and aortic insufficiency (AS/AI) disease for which isolated surgical aortic valve replacement without concomitant procedures is indicated according to International guidelines.
- Surgery starts with and is intended to be completed via a minimal invasive surgical approach. MIS is defined as a non-full sternotomy approach such as partial hemi-sternotomy, right anterior thoracotomy.
- Surgery is intended to be completed with an EDWARDS INTUITY Elite Heart Valve.
- Subject has signed and dated the investigation informed consent forms prior to any study-specific procedures are performed.
- Subject is geographically stable and agrees to attend follow-up assessments as specified in the protocol and informed consent.
Exclusion Criteria
- Subject is diagnosed with pure aortic insufficiency.
- Subject requires multiple valve replacement/repair
- Subject has Type 0 congenital true bicuspid aortic valve (i.e. absence of raphe and commissures are positioned about 180 degrees apart) or unicuspid aortic valve.
- Subject has severe ventricular dysfunction defined as LVEF < 25%.
- Subject has a history of active endocarditis and/or myocarditis ≤ 3 months before the intended treatment/scheduled surgery.
- Subject has had an acute MI ≤ 3 months before the intended treatment.
- Subject had a stroke or transient ischemic attack within six months prior to scheduled aortic valve replacement surgery.
- Subject is oxygen or ventilator dependent.
- Subject has life expectancy < 12 months.
- Female subject is pregnant or lactating.
- Subject with documented leukopenia (WBC < 3.5x 103/μL), anemia (Hb < 10.0 gm/dL or < 6.2 mmol/L), thrombocytopenia (platelet count < 100x 103/mL), or history of bleeding diathesis or coagulopathy.
- Subject has renal insufficiency as determined by Serum creatinine
≥ 200 μmol/L (2.27 mg/dL) at screening or end-stage renal disease requiring chronic dialysis.
- Subject is currently participating in an investigational drug or device trial for which follow-up has not yet been completed.
- Minimally Invasive access to the heart is not possible due to anatomical constraints or any other pre-existing condition.
- Aneurysm of the aortic root and/or ascending aorta
Intra-operative exclusion criteria:
- Subject has Type 0 congenital true bicuspid aortic valve (i.e. absence of raphe and commissures are positioned about 180 degrees apart) or unicuspid aortic valve. (A non-congenital bicuspid valve without a distorted annulus would not be cause for exclusion.)
- Subject has calcium on the anterior mitral leaflet which cannot be removed.
- Subject has extensive calcification of the aortic root.
- Annular deformation which may or may not be caused by too extensive decalcification of the aortic annulus.
- The position of the coronary ostia relative to the EDWARDS INTUITY Elite Aortic Valve could result in obstruction of blood flow.
- Minimally Invasive access to the heart is not possible due to anatomical constraints or any other condition (including patient switched to a full sternotomy approach).
- The device is not available in the correct size for the subject.
Data sourced from ClinicalTrials.gov (NCT02907463). 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.