Aortic Valve StenosisINCANCT03326778
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)
An observational study of Aortic Valve Stenosis and Coronary Artery Disease, run by Campus Bad Neustadt at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Coronary Artery Disease
- What is being tested?
- AVR and CABG
- Type of treatment
- Surgery or procedure
- How many people
- 220 participants
- Where
- 1 siteGermany
- Study dates
- 26 Nov 2017to 1 Jul 2020
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an indication for AVR combined with CABG who will receive an Edwards Intuity Elite rapid deployment aortic valve prosthesis.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Register Zur Erhebung Von Langzeitergebnissen Nach Chirurgischem Aortenklappen Ersatz Mit Einer "Rapid Deployment" Aortenklappenprothese (Edwards Intuity) in Kombination Mit Einer Bypassoperation (CABG)
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.
Read the 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
- Aortic Valve Stenosis, Coronary Artery Disease
- Being tested
- AVR and CABG
- Keywords
- Aortic Valve Stenosis, Rapid deployment Valve, CABG, Edwards Intuity Elite
- Medical subject headings
- Aortic Valve Stenosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVR and CABGProcedure or surgery
Combined AVR with CABG
| Study group | Role | What they receive |
|---|---|---|
| AVR + CABG | Patient receiving AVR combined with CABG Receives: Procedure: AVR and CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
death from any reason
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start26 Nov 2017
- Primary completion6 Dec 2019
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Campus Bad Neustadt
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences, Software for Trials Europe GmbH, Institut für Pharmakologie und Präventive Medizin
- Responsible party
- Sponsor
- Investigators
- Anno Diegeler, Prof., Principal investigator, Campus Bad Neustadt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326778
- Sponsor's protocol ID
- INCA
- Acronym
- INCA
- Status last verified
- Aug 2021
- First submitted
- 27 Oct 2017
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Register Zur Erhebung Von Langzeitergebnissen Nach Chirurgischem Aortenklappen Ersatz Mit Einer "Rapid Deployment" Aortenklappenprothese (Edwards Intuity) in Kombination Mit Einer Bypassoperation (CABG)
- ClinicalTrials.gov ID
- NCT03326778
- Acronym / sponsor ID
- INCA / INCA
- Conditions
- Aortic Valve Stenosis, Coronary Artery Disease
- Keywords
- Aortic Valve Stenosis, Rapid deployment Valve, CABG, Edwards Intuity Elite
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Campus Bad NeustadtUniversity, hospital or other
- Collaborators
- Edwards Lifesciences, Software for Trials Europe GmbH, Institut für Pharmakologie und Präventive Medizin
- Study start
- 26 Nov 2017 (actual)
- Primary completion
- 6 Dec 2019 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 31 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AVR + CABG | – | Procedure: AVR and CABGPatient receiving AVR combined with CABG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an indication for AVR combined with CABG who will receive an Edwards Intuity Elite rapid deployment aortic valve prosthesis.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVR and CABGCombined AVR with CABG | Procedure or surgery | AVR + CABG |
Primary outcome
all-cause mortality
Time frame: 30 Days
death from any reason
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anno Diegeler, Prof. principal investigator
Campus Bad Neustadt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis and Coronary Artery Disease, run by Campus Bad Neustadt at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.