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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)

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03326778
Acronym
INCA
Enrollment
220
Registered
2017-10-31
Start date
2017-11-26
Completion date
2020-07-01
Last updated
2021-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis, Coronary Artery Disease

Keywords

Aortic Valve Stenosis, Rapid deployment Valve, CABG, Edwards Intuity Elite

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.

Interventions

PROCEDUREAVR and CABG

Combined AVR with CABG

Sponsors

Edwards Lifesciences
CollaboratorINDUSTRY
Software for Trials Europe GmbH
CollaboratorUNKNOWN
Institut für Pharmakologie und Präventive Medizin
CollaboratorNETWORK
Campus Bad Neustadt
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

*

Design outcomes

Primary

MeasureTime frameDescription
all-cause mortality30 Daysdeath from any reason

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026