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)
INCA
Register Zur Erhebung Von Langzeitergebnissen Nach Chirurgischem Aortenklappen Ersatz Mit Einer "Rapid Deployment" Aortenklappenprothese (Edwards Intuity) in Kombination Mit Einer Bypassoperation (CABG)
1 other identifier
observational
220
1 country
1
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 patient specific baseline data and established risk scores (Logistic Euroscore I \& II, STS-Score, KBA Score) to enable us to make an estimate about the perioperative risks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2017
CompletedFirst Posted
Study publicly available on registry
October 31, 2017
CompletedStudy Start
First participant enrolled
November 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedAugust 26, 2021
August 1, 2021
2 years
October 27, 2017
August 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
all-cause mortality
death from any reason
30 Days
Study Arms (1)
AVR + CABG
Patient receiving AVR combined with CABG
Interventions
Eligibility Criteria
Patients with an indication for AVR combined with CABG who will receive an Edwards Intuity Elite rapid deployment aortic valve prosthesis.
You may qualify if:
- 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
You may not qualify if:
- emergency surgery
- re-operation (i.e. any previous opening of pericardium)
- additional heart diseases requiring heart surgery (e. g. subvalvular myectomy and ablation, but not atrial auricle closure or resection)
- legal incapacity or other circumstances that impair the patient's ability to understand the nature, meaning or extent of the trial
- patients wanting a mechanical prosthesis
- patients with contraindications for the Edwards Intuity Elite Valve
- acute endocarditis or other systemic infections
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Campus Bad Neustadtlead
- Edwards Lifesciencescollaborator
- Software for Trials Europe GmbHcollaborator
- Institut für Pharmakologie und Präventive Medizincollaborator
Study Sites (1)
Campus Bad Neustadt
Bad Neustadt an der Saale, Bavaria, 97616, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anno Diegeler, Prof.
Campus Bad Neustadt
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2017
First Posted
October 31, 2017
Study Start
November 26, 2017
Primary Completion
December 6, 2019
Study Completion
July 1, 2020
Last Updated
August 26, 2021
Record last verified: 2021-08