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)

Completed

• Conditions: Aortic Valve Stenosis; Coronary Artery Disease
• Interventions: Procedure: AVR and CABG

• Registration Number: NCT03326778
• Lead Sponsor: Campus Bad Neustadt

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.

Study Timeline

• Study First Submitted: 2017-10-27
• Study First Submitted QC: 2017-10-27
• Study First Posted: 2017-10-31
• Study Start: 2017-11-26
• Primary Completion: 2019-12-06
• Study Completion: 2020-07-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-25
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AVR + CABG	AVR and CABG	Patient receiving AVR combined with CABG

Primary Outcome Measures

Name	Time	Method
all-cause mortality	30 Days	death from any reason

Trial Locations

Locations (1)

Campus Bad Neustadt; 🇩🇪 Bad Neustadt An Der Saale, Bavaria, Germany