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)

Coronary Artery Disease Clinical Trial

— INCA  

Official title:

Register Zur Erhebung Von Langzeitergebnissen Nach Chirurgischem Aortenklappen Ersatz Mit Einer "Rapid Deployment" Aortenklappenprothese (Edwards Intuity) in Kombination Mit Einer Bypassoperation (CABG)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03326778
• Other study ID #: INCA
• Status: Completed
• Start date: November 26, 2017
• Est. completion date: July 1, 2020

Study information

• Verified date: August 2021
• Source: Campus Bad Neustadt
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: July 1, 2020
• Est. primary completion date: December 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Coronary Artery Disease

Intervention

Procedure:
• AVR and CABG
Combined AVR with CABG

Locations

Country	Name	City	State
Germany	Campus Bad Neustadt	Bad Neustadt An Der Saale	Bavaria

Sponsors (4)

Lead Sponsor	Collaborator
Campus Bad Neustadt	Edwards Lifesciences, Institut für Pharmakologie und Präventive Medizin, Software for Trials Europe GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all-cause mortality	death from any reason	30 Days