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)
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ClinicalTrials.gov Identifier: NCT03326778 |
Recruitment Status :
Completed
First Posted : October 31, 2017
Last Update Posted : August 26, 2021
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Condition or disease | Intervention/treatment |
---|---|
Aortic Valve Stenosis Coronary Artery Disease | Procedure: AVR and CABG |
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 Type : | Observational [Patient Registry] |
Actual Enrollment : | 220 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 5 Years |
Official Title: | Register Zur Erhebung Von Langzeitergebnissen Nach Chirurgischem Aortenklappen Ersatz Mit Einer "Rapid Deployment" Aortenklappenprothese (Edwards Intuity) in Kombination Mit Einer Bypassoperation (CABG) |
Actual Study Start Date : | November 26, 2017 |
Actual Primary Completion Date : | December 6, 2019 |
Actual Study Completion Date : | July 1, 2020 |

Group/Cohort | Intervention/treatment |
---|---|
AVR + CABG
Patient receiving AVR combined with CABG
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Procedure: AVR and CABG
Combined AVR with CABG |
- all-cause mortality [ Time Frame: 30 Days ]death from any reason

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03326778
Germany | |
Campus Bad Neustadt | |
Bad Neustadt An Der Saale, Bavaria, Germany, 97616 |
Principal Investigator: | Anno Diegeler, Prof. | Campus Bad Neustadt |
Responsible Party: | Campus Bad Neustadt |
ClinicalTrials.gov Identifier: | NCT03326778 |
Other Study ID Numbers: |
INCA |
First Posted: | October 31, 2017 Key Record Dates |
Last Update Posted: | August 26, 2021 |
Last Verified: | August 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Aortic Valve Stenosis Rapid deployment Valve CABG Edwards Intuity Elite |
Coronary Artery Disease Aortic Valve Stenosis Coronary Disease Myocardial Ischemia Heart Diseases Cardiovascular Diseases |
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Aortic Valve Disease Heart Valve Diseases Ventricular Outflow Obstruction |