Clinical trial NCT03326778: 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)
Official title: Register Zur Erhebung Von Langzeitergebnissen Nach Chirurgischem Aortenklappen Ersatz Mit Einer "Rapid Deployment" Aortenklappenprothese (Edwards Intuity) in Kombination Mit Einer Bypassoperation (CABG)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Coronary Artery Disease
Keywords: Aortic Valve Stenosis
Rapid deployment Valve
CABG
Edwards Intuity Elite
Lead sponsor: Campus Bad Neustadt
Sponsor class: OTHER
Collaborators: name: Edwards Lifesciences
name: Software for Trials Europe GmbH
name: Institut für Pharmakologie und Präventive Medizin
First posted: 2017-10-31
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an indication for AVR combined with CABG who will receive an Edwards Intuity Elite rapid deployment aortic valve prosthesis.

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.

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 deployment aortic valve prostheses, like the Edward Intuity Elite Valve that is used in this registry, is the greater ease of implantation, because only a few sutures are necessary to secure the device compared to a conventional prosthesis, where more then ten sutures are needed. In procedures where the aortic valve replacement (AVR) is combined with a coronary artery bypass graft (CABG), the use of a rapid deployment valve can shorten the duration of cardiac ischemia and the overall intervention duration, which possibly has an influence on clinical results.

Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria:
* 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 Criteria:

* Exclusion Criteria:
* 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

Primary outcomes:
measure: all-cause mortality
timeFrame: 30 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Neustadt An Der Saale
country: Germany
facility: Campus Bad Neustadt
state: Bavaria
Study officials:
affiliation: Campus Bad Neustadt
name: Anno Diegeler, Prof.
role: PRINCIPAL_INVESTIGATOR
References: