N/A N=120 Randomized Treatment

EDWARDS INTUITY Valve System CADENCE Study

Aortic Valve Disease · Aortic Stenosis

Bottom Line

View on ClinicalTrials.gov: NCT02688153 ↗

Enrolled (actual)

120

Serious AEs

66.7%

Results posted

Jun 2018

Primary outcome: Primary: Average Subject Time Spent on Cardiopulmonary Cross Clamp — 77.5; 82.0 Minutes — p=0.3660

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: EDWARDS INTUITY (Device); Stented aortic bioprostheses (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Edwards Lifesciences
Primary completion: Apr 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Average Subject Time Spent on Cardiopulmonary Cross Clamp	77.5; 82.0	0.3660
PRIMARY Average Amount of Time Subject Spent on Cardiopulmonary Bypass	109.0; 107.0	0.8377
SECONDARY Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years.	40; 43; 6; 9; 0; 1	—
SECONDARY Subject's Average Mean Gradients (mmHg) Measurements Over Time.	10.6; 10.1; 10.7; 11.1; 11.7; 11.4	—
SECONDARY Subject's Average Peak Gradients (mmHg) Measurements Over Time.	19.8; 18.4; 19.5; 20.2; 21.1; 20.6	—
SECONDARY Subject's Effective Orifice Area (EOA) Measurement Over Time.	1.7; 1.6; 1.8; 1.6; 1.7; 1.6	—
SECONDARY Subject's Effective Orifice Area Index (EOAI) Measurement Over Time.	1.0; 0.9; 1.0; 0.9; 0.9; 0.9	—
SECONDARY Amount of Aortic Valvular Regurgitation Over Time.	30; 38; 12; 13; 1; 0	—
SECONDARY Conversion of Edwards INTUITY Surgical Aortic Valve to Control During Surgery.	3; 0	—
SECONDARY Subjects Who Required a Thoracic Resternotomy Over Time	6; 8; 6; 8; 6; 8	—
SECONDARY Subjects Who Received a Permanent Pacemaker Over Time.	1; 4; 1; 5; 1; 6	—
SECONDARY Subjects With a Major Paravalvular Leak (OPC) Over Time	1; 0; 1; 0; 1; 0	—
SECONDARY Subjects Who Experienced Major Bleeding Over Time.	12; 16; 13; 17; 15; 17	—
SECONDARY Subjects Who Experienced Respiratory Failure Over Time	3; 1; 3; 1; 3; 1	—
SECONDARY Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time	0; 0; 0; 1; 0; 2	—
SECONDARY Subjects With Renal Failure Over Time	2; 1; 2; 1; 2; 1	—
SECONDARY Subjects With Endocarditis Over Time	0; 0; 0; 0; 0; 1	—
SECONDARY Subjects With a Deep Sternal Would Infection Over Time	0; 0; 1; 0; 1; 0	—
SECONDARY Subjects With a Myocardial Infarction Over Time	2; 0; 2; 1; 3; 1	—
SECONDARY Subjects With a Thromboembolism Over Time	2; 0; 2; 2; 3; 3	—
SECONDARY Subjects With a Cardiac Tamponade Over Time	3; 2; 3; 2; 3; 2	—
SECONDARY Subjects With a Cardiac Reoperation for Any Reason Over Time	6; 9; 6; 11; 9; 12	—
SECONDARY Subjects Who Died Intraoperatively	0; 0	—
SECONDARY Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time	0.773; 0.723; 0.790; 0.771; 0.850; 0.808	—
SECONDARY Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time	40.67; 39.47; 40.57; 41.16; 44.17; 43.73	—
SECONDARY Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time	64.50; 57.50; 71.44; 69.24; 83.20; 78.26	—
SECONDARY Health Care Utilization	12.0; 10.5; 3.9; 2.9; 1.2; 1.2	—

Summary

The study purpose is to compare the EDWARDS INTUITY valve system with commercially available stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with coronary artery bypass.

Eligibility Criteria

Inclusion:

≥18 years of age
aortic stenosis / mixed aortic stenosis and aortic insufficiency
SAVR+CABG (1-4 distal anastomoses)
Log. EuroSCORE ≥6
NYHA Class ≥II

Exclusion (i.a.):

pure aortic insufficiency
pre-existing prosthetic heart valve or ring
congenital true bicuspid / unicuspid aortic valve
LVEF <20%

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02688153). 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.