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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Tracking Information | |||||||
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First Submitted Date | October 27, 2017 | ||||||
First Posted Date | October 31, 2017 | ||||||
Last Update Posted Date | August 26, 2021 | ||||||
Actual Study Start Date | November 26, 2017 | ||||||
Actual Primary Completion Date | December 6, 2019 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
all-cause mortality [ Time Frame: 30 Days ] death from any reason
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Original Primary Outcome Measures | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures | Not Provided | ||||||
Original Secondary Outcome Measures | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title | 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) | ||||||
Official Title | Register Zur Erhebung Von Langzeitergebnissen Nach Chirurgischem Aortenklappen Ersatz Mit Einer "Rapid Deployment" Aortenklappenprothese (Edwards Intuity) in Kombination Mit Einer Bypassoperation (CABG) | ||||||
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. |
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Study Type | Observational [Patient Registry] | ||||||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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Target Follow-Up Duration | 5 Years | ||||||
Biospecimen | Not Provided | ||||||
Sampling Method | Non-Probability Sample | ||||||
Study Population | Patients with an indication for AVR combined with CABG who will receive an Edwards Intuity Elite rapid deployment aortic valve prosthesis. | ||||||
Condition |
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Intervention | Procedure: AVR and CABG
Combined AVR with CABG
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Study Groups/Cohorts | AVR + CABG
Patient receiving AVR combined with CABG
Intervention: Procedure: AVR and CABG
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Completed | ||||||
Actual Enrollment |
220 | ||||||
Original Estimated Enrollment |
750 | ||||||
Actual Study Completion Date | July 1, 2020 | ||||||
Actual Primary Completion Date | December 6, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | Germany | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT03326778 | ||||||
Other Study ID Numbers | INCA | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Current Responsible Party | Campus Bad Neustadt | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor | Campus Bad Neustadt | ||||||
Original Study Sponsor | Same as current | ||||||
Collaborators |
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Investigators |
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PRS Account | Campus Bad Neustadt | ||||||
Verification Date | August 2021 |