Trials / Completed
CompletedNCT03326778
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 220 (actual)
- Sponsor
- Campus Bad Neustadt · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | AVR and CABG | Combined AVR with CABG |
Timeline
- Start date
- 2017-11-26
- Primary completion
- 2019-12-06
- Completion
- 2020-07-01
- First posted
- 2017-10-31
- Last updated
- 2021-08-26
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03326778. Inclusion in this directory is not an endorsement.