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)

Campus Bad Neustadt

Status: Completed

Conditions: Coronary Artery Disease; Aortic Valve Stenosis

Treatments: Procedure: AVR and CABG

Study type: Observational

Funder types: Other; NETWORK; Industry

Identifiers

NCT03326778

INCA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

220 participants in 1 patient group

AVR + CABG

Description:

Patient receiving AVR combined with CABG

Treatment:

Procedure: AVR and CABG