Status:
COMPLETED
Registry to Gather Long-time Results After Surgical Aortic Valve Replacement With a "Rapid Deployment Aortic Valve Prothesis (Edwards Intuity) Combined With Bypss Surgery (CABG)
Lead Sponsor:
Campus Bad Neustadt
Collaborating Sponsors:
Edwards Lifesciences
Software for Trials Europe GmbH
Conditions:
Aortic Valve Stenosis
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Brief Summary
This is a prospctive, unrandomized multicentric registry which will enrol patients with an indication for aortc valve replacement combined with myocardial reperfusion (CABG). The registry will collect...
Detailed Description
Aortic replacement combined with coronary bypass surgery has an impact on the risk profile for the direct postoperative course and also on the long-time survival perspective. The advantage of rapid d...
Eligibility Criteria
Inclusion
- patients with aortic valve stenosis and coronary heart disease with indication for AVR and CABG
- patients in who the Edwards Intuity Elite valve is to be implanted
- patients who are planned to receive at least one coronary bypass
- patients who have signed an informed consent form
Exclusion
Key Trial Info
Start Date :
November 26 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2020
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT03326778
Start Date
November 26 2017
End Date
July 1 2020
Last Update
August 26 2021
Active Locations (1)
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1
Campus Bad Neustadt
Bad Neustadt an der Saale, Bavaria, Germany, 97616