N/A
N=100
EDWARDS INTUITY Valve System CADENCE-MIS Study
Aortic Valve Disease · Aortic Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT02672553 ↗Enrolled (actual)
100
Serious AEs
59.8%
Results posted
Jan 2019
Primary outcome: Primary: Median Subject Time Spent on Cardiopulmonary Cross Clamp — 35.0; 47.5 Minutes — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EDWARDS INTUITY Valve System, Model 8300A (Device); Stented Aortic Bioprostheses (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Edwards Lifesciences
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Subject Time Spent on Cardiopulmonary Cross Clamp |
35.0; 47.5 | <0.0001 sig |
| PRIMARY Median Amount of Time Subject Spent on Cardiopulmonary Bypass |
58.5; 69.0 | 0.2077 |
| SECONDARY Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years. |
22; 27; 17; 11; 1; 1 | — |
| SECONDARY Subject's Average Mean Gradients (mmHg) Measurements Over Time. |
44.0; 45.4; 10.3; 10.8; 8.8; 9.7 | — |
| SECONDARY Subject's Average Peak Gradients (mmHg) Measurements Over Time. |
69.6; 75.4; 19.0; 21.0; 16.5; 17.8 | — |
| SECONDARY Subject's Effective Orifice Area (EOA) Measurement Over Time. |
0.7; 0.7; 1.9; 1.9; 1.9; 2.0 | — |
| SECONDARY Amount of Paravalvular Leak Over Time. |
30; 33; 10; 7; 1; 3 | — |
| SECONDARY Conversion of Edwards INTUITY Surgical Aortic Valve to Control Surgical Aortic Heart Valves During Surgery. |
3; 0 | — |
| SECONDARY Subjects Who Required a Thoracic Resternotomy Over Time |
6; 5; 6; 5; 7; 5 | — |
| SECONDARY Subjects Who Received a Permanent Pacemaker Over Time. |
2; 1; 2; 1; 2; 1 | — |
| SECONDARY Subjects With a Paravalvular Leak > or Equal to 3+ and/or Requiring Intervention Over Time |
0; 1; 0; 1; 2; 1 | — |
| SECONDARY Subjects Who Experienced Major Bleeding Over Time. |
8; 4; 8; 5; 8; 5 | — |
| SECONDARY Subjects Who Experienced Respiratory Failure Over Time |
2; 0; 2; 0; 2; 2 | — |
| SECONDARY Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time |
2; 2; 2; 2; 2; 2 | — |
| SECONDARY Subjects With Renal Failure Over Time |
3; 0; 3; 0; 3; 1 | — |
| SECONDARY Subjects With Endocarditis Over Time |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Subjects With a Deep Sternal Would Infection Over Time |
1; 1; 1; 1; 1; 1 | — |
| SECONDARY Subjects With a Myocardial Infarction Over Time |
0; 1; 0; 1; 0; 2 | — |
| SECONDARY Subjects With a Thromboembolism Over Time |
3; 3; 3; 3; 4; 4 | — |
| SECONDARY Subjects With a Cardiac Tamponade Over Time |
2; 3; 2; 3; 2; 3 | — |
| SECONDARY Subjects With a Cardiac Reoperation for Any Reason Over Time |
6; 5; 6; 5; 7; 6 | — |
| SECONDARY Conversion of Subjects Undergoing Minimally Invasive Surgical Incision to Full Sternotomy for the Randomized to Edwards INTUITY Group During Surgery. |
0; 0 | — |
| SECONDARY Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time |
0.900; 0.902; 0.862; 0.902; 0.908; 0.918 | — |
| SECONDARY Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time |
42.39; 40.79; 36.16; 38.45; 41.42; 43.95 | — |
| SECONDARY Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time |
58.37; 61.33; 57.81; 64.33; 69.32; 76.35 | — |
| SECONDARY Health Care Utilization |
10.9; 11.5; 2.6; 1.6; 1.3; 0.9 | — |
| SECONDARY Subject's Effective Orifice Area Index (EOAI) Measurement Over Time. |
0.4; 0.4; 0.9; 1.0; 1.0; 1.1 | — |
| SECONDARY Amount of Aortic Valvular Regurgitation Over Time. |
29; 29; 10; 13; 1; 2 | — |
Summary
The study purpose is to compare the EDWARDS INTUITY valve system in a minimal invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach.
Eligibility Criteria
Inclusion:
- adult male or female ≥18 years of age
- symptomatic for aortic stenosis / mixed aortic stenosis and aortic insufficiency disease for which isolated surgical aortic valve replacement without concomitant procedures is planned
- EuroSCORE <20
- NYHA Class ≥II
- Subject has signed and dated the investigation informed consent form prior to study specific procedures are performed
- Subject is geographically stable and agrees to participate in follow-up assessments as specified in the protocol and informed consent
Exclusion (i.a.):
- pure aortic insufficiency
- previous cardiac surgery (involved FS or MIS approach)
- congenital true bicuspid / unicuspid aortic valve
- requires emergency surgery or has had emergency surgery for any reason
≤ 1 month before the intended treatment
- LVEF <25%
- active endocarditis ≤ 6 months before the intended treatment
- acute MI ≤ 90 days before the intended treatment
- had a stroke or transient ischemic attack within six months prior to scheduled aortic valve replacement surgery
- oxygen or ventilator dependent
- life expectancy < 12 months
- substance abuser
- Female subject is pregnant or lactating
- documented leukopenia (WBC < 3.5x 103/μL), acute anemia (Hgb < 10.0 gm/dL or < 6.2 mmol/L), thrombocytopenia (platelet count < 100x 103/mL), or history of bleeding diathesis or coagulopathy
- hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days of procedure
- documented echocardiographic evidence of intracardiac mass, thrombus or vegetation
- renal insufficiency as determined by Serum creatinine ≥ 200 μmol/L (2.27 mg/dL) at screening or end-stage renal disease requiring chronic dialysis
- documented hyperparathyroidism
- 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
Intra-operative Exclusion:
- has calcium on the anterior mitral leaflet which cannot be removed
- has extensive calcification of the aortic root
- Annular deformation which may or may not be caused by too extensive decalcification of the aortic annulus
- has left atrial thrombus
- The position of the coronary ostia relative to the EDWARDS INTUITY Valve would result in obstruction of blood flow
- hemodynamically unstable during the procedure requiring the procedure to be aborted prior to insertion of the study bioprosthesis and delivery system
- Study device is not available in the correct size for the subject
Data sourced from ClinicalTrials.gov (NCT02672553). 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.