Overview

This trial is active, not recruiting.

Conditions aortic valve disease, aortic stenosis
Treatments edwards intuity, stented aortic bioprostheses
Phase phase 4
Sponsor Edwards Lifesciences
Start date October 2012
End date April 2016
Trial size 120 participants
Trial identifier NCT02688153, 2011-11

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
EDWARDS INTUITY Valve System, Model 8300A
edwards intuity aortic stenosis
To evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing AVR & CABG.
(Active Comparator)
Stented aortic bioprostheses
stented aortic bioprostheses aortic stenosis
In comparison to control valves available on the market.

Primary Outcomes

Measure
Cross-clamp time
time frame: At time of surgery
Cardiopulmonary bypass time
time frame: At time of surgery

Secondary Outcomes

Measure
NYHA (assessed during follow up)
time frame: Discharge, 30 days, 3 Months ,6 Months, 1 Year, 2 Years.
EQ-5D-questionaire (6 questions)
time frame: Discharge, 30 days, 3 Months ,6 Months, 1 Year, 2 Years.
Safety Endpoints (Adverse Events observed after surgery)
time frame: Discharge, 30 days, 3 Months ,6 Months, 1 Year, 2 Years.
Gradients (mmHg)
time frame: Discharge, 30 days, 3 Months ,6 Months, 1 Year, 2 Years.
VTI (cm)
time frame: Discharge, 30 days, 3 Months ,6 Months, 1 Year, 2 Years.
LVOT Diameter (cm)
time frame: Discharge, 30 days, 3 Months ,6 Months, 1 Year, 2 Years.
Annulus size (cm)
time frame: Discharge, 30 days, 3 Months ,6 Months, 1 Year, 2 Years.
Septal thickness (cm)
time frame: Discharge, 30 days, 3 Months ,6 Months, 1 Year, 2 Years.

Eligibility Criteria

Male or female participants at least 18 years old.

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%

Additional Information

Official title A Randomized Comparison of the EDWARDS INTUITY Valve System anD commErcially Available Aortic Bioprostheses in Subjects uNdergoing surgiCal Aortic Valve replacEment
Principal investigator Prof. Labrousse, MD
Description This is a randomized study comparing the cross-clamp time (XCT) and cardiopulmonary bypass time (CPBT) of the EDWARDS INTUITY valve system with any commercially available stented aortic bioprosthesis, in patients with logistic EuroSCORE 1 ≥ 8 undergoing elective surgical aortic valve replacement surgery with concomitant coronary bypass grafts. Additionally, the aim is to gather sufficient data to quantify the effect size of short term patient benefit outcomes previously identified from literature and finally to explore additional healthcare resource utilization or health economic endpoints.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Edwards Lifesciences.