Postoperative DeliriumCOSTANCT04535076
Cognitive Outcome After Surgical and Transcatheter Aortic Valve Replacement
A study testing Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement in people with Postoperative Delirium and Postoperative Cognitive Dysfunction, run by Heart and Brain Research Group, Germany at 1 site in Germany.
Trial summary
Aortic valve stenosis is one of the most common types of heart disease in the aging Western population. While surgical cardiac valve replacement (SAVR) is a standard therapy for patients with aortic stenosis, catheter-assisted aortic valve implantation (TAVI) has developed as an alternative to open-heart surgery… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Postoperative Delirium, Postoperative Cognitive Dysfunction, Transcatheter Aortic Valve Replacement
- What is being tested?
- Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteGermany
- Study dates
- 28 Feb 2019to 19 Dec 2022
- Phase
- Interventional
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Heart team decision that both TAVI and SAVR are medically justified based on
- Degenerative aortic valve stenosis:
- Mean gradient > 40 mmHg or
- Jet velocity > 40 m/s or
- Surface of aortic valve < 1.0 cm²
- Patient shows symptoms of aortic stenosis
Show all 17Show fewer
- NYHA functional class ≥ II or
- Angina pectoris or
- Syncope
- Low to intermediate surgical risk (STS: 2-6%)
- A transfemoral or alternative access for TAVI can be implemented
- Patient has agreed in writing to participate in the study
- Patient is able to understand the patient information and sign it personally
- Patient agrees to undergo SAVR if randomization into the control group occurs
- Readiness for MRT examination and neuropsychological testing after 3 months
- Patients aged 65 to 85 years.
- Native German speaker (since a neuropsychological test is language dependent)
Who cannot join
- Congenital aortic valve defects
- Untreated clinically significant coronary artery disease or severe mitral or tricuspid insufficiency or mitral stenosis
- Previous heart surgery
- Percutaneous coronary intervention performed within one month prior to the study
- Hemodynamic instability requiring inotropic support or mechanical circulatory support
- Ischemic stroke or intracranial bleeding within the month before the start of the study
Show all 13Show fewer
- Severe ventricular dysfunction with left ventricular ejection fraction < 20% as measured by echocardiogram
- Hypertrophic obstructive cardiomyopathy or severe basal septum hypertrophy
- Echocardiographic detection of intracardiac mass, thrombus, vegetation, or endocarditis
- Any other atherosclerotic disease that is considered as a contraindication for isolated aortic valve surgery
- Symptomatic carotid or vertebral artery disease
- Existing neurological or psychiatric disease (particularly cerebral infarction, cranio- cerebral trauma, manifest depression or dementia) that may interfere with neuropsychological testing.
- Contraindications for MRI examination (e.g. cardiac pacemaker, vena cava filter, claustrophobia)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Cardiac Surgery, Kerckhoff-Klinik GmbH
Bad Nauheim, 61231
About this study
Aortic valve stenosis is one of the most common types of heart disease in the aging Western population. While surgical cardiac valve replacement (SAVR) is a standard therapy for patients with aortic stenosis, catheter-assisted aortic valve implantation (TAVI) has developed as an alternative to open-heart surgery, especially for high-risk patients. Recently, increased surgeon experience and improved transcatheter valve systems have led to a global trend to use TAVI in patients with low or intermediate risk. Although cognitive impairment after cardiac surgery is well known, the effect of TAVI on cognitive function has not yet been adequately investigated. The aim of this study is to compare the occurrence and progression of delirium, postoperative cognitive decline (POCD), cerebral infarction, and health-related quality of life (QOL) in patients with intermediate risk for catheter-assisted (TAVI) and surgical (SAVR) aortic valve replacement.
Read the detailed description
The present project is a substudy of the DEDICATE Trial (ID: NCT03112980). It is a randomized intervention study taking place at the Kerckhoff-Klink Bad Nauheim Germany (Campus Justus Liebig University Giessen) involving 100 patients undergoing aortic valve replacement (TAVI vs. SAVR) with a focus on cognitive outcome. A detailed assessment of psychological and health-related functions will be performed before intervention, during hospitalization and 3 months after intervention. During hospitalization, the occurrence and progression of delirium will be assessed with the Intensive Care Delirium Screening Checklist (ICDSC). Other cognitive data will be collected before and 3 months after surgery with a selected and comprehensive neuropsychological test battery, including the evaluation of attention, word fluency, executive functions and various functional areas of memory. In addition, parameters of health-related QOL will be collected before and 3 months after the intervention using the SF-36, and information on anxiety and depression will be collected using the Hospital Anxiety and Depression Scale (HADS). A few days after the intervention, magnetic resonance images of the brain will be acquired to assess cerebral infarction.
- Conditions
- Postoperative Delirium, Postoperative Cognitive Dysfunction, Transcatheter Aortic Valve Replacement, Surgical Aortic Valve Replacement
- Being tested
- Transcatheter Aortic Valve Implantation, Surgical Aortic Valve Replacement
- Medical subject headings
- Emergence Delirium, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve ImplantationProcedure or surgery
Transcatheter Aortic Valve Implantation
Surgical Aortic Valve ReplacementProcedure or surgery
Surgical Aortic Valve Replacement
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter Aortic Valve Implantation | Experimental | Not described Receives: Procedure: Transcatheter Aortic Valve Implantation |
| Surgical Aortic Valve Replacement | Active comparator | Not described Receives: Procedure: Surgical Aortic Valve Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with postoperative cognitive decline at 3 months after surgery, defined as a decrease between pre- and postoperative examinations of one standard deviation in at least 20% of all objective neuropsychological parameters
The objective neuropsychological parameters measure cognitive domains like immediate memory span, free recall, recognition memory, selective attention, working memory, inhibition and word fluency. These cognitive domains will be measured with the following instruments: "Verbaler Lern- und Merkfähigkeitstest" (VLMT), "Trail Making Test A/B" (TMT), "Letter Number Span Test" (LNS), Block Tapping Test (BTT), "Regensburger Wortflüssigkeits-Test" (RWT), and "Syndrom-Kurz Test" (SKT).
Measured: Immediately pre-surgery to 3 months post-surgery
Number of participants with postoperative cognitive decline at the time of discharge from the acute clinic, defined as a decrease between the pre- and postoperative examinations of one standard deviation measured with the "Montreal Cognitive Assessment"
The "Montreal Cognitive Assessment" (MOCA) is a screening procedure for general cognitive function.
Measured: Immediately pre-surgery to approximately 1 week post-surgery
Number of participants with postoperative delirium during the stay in the intensive care unit as assessed by the "Intensive Care Delirium Screening Checklist" (ICDSC)
Postoperative delirium is defined as the occurrence of at least one delirious episode during a stay in the intensive care unit. The "Intensive Care Delirium Screening Checklist" (ICDSC) record the clinical symptoms of consciousness, attention, orientation, hallucinations, psychomotor retardation or agitation, speech, and changing symptoms by observing behavior and asking concrete questions to the patient.
Measured: Immediately post-surgery to approximately 7 days post-surgery
Secondary outcomes (6)
Change from baseline cognitive failures in everyday life at 3 months after surgery as assessed by the "Cognitive Failures Questionnaire" (CFQ)
The "Cognitive Failures Questionnaire" (CFQ) measure the frequency of failures in daily living in terms of memory, attention, action, and perception. It comprises 29 questions, which are answered on a 5-step Likert scale. Higher scores mean a worse outcome.
Measured: Immediately pre-surgery to 3 months post-surgery
Change from baseline health-related quality of life at 3 months after surgery as assessed by the "36-Item Short Form Health Survey" (SF36)
The "36-Item Short Form Health Survey" (SF36) includes 36 questions covering 8 health-related factors: vitality, physical functioning, bodily pain, general health perception, physical role function, emotional role function, social role functioning, and mental health. An aggregated percentage score is calculated for each of the eight factors. The percentage scores range from 0% to 100%. Higher scores mean a better outcome.
Measured: Immediately pre-surgery to 3 months post-surgery
Change from baseline anxiety at 3 months after surgery as assessed by the "Hospital Anxiety and Depression Scale" (HADS).
With the "Hospital Anxiety and Depression Scale" (HADS), an instrument will be used that refers to the psychological core aspects of depression and anxiety. Each scale contains 7 questions to be answered on a 4-step Likert scale by the patients themselves. After inverting negative questions, higher scores mean a worse outcome.
Measured: Immediately pre-surgery to 3 months post-surgery
Change from baseline depression at 3 months after surgery as assessed by the "Hospital Anxiety and Depression Scale" (HADS).
With the "Hospital Anxiety and Depression Scale" (HADS), an instrument will be used that refers to the psychological core aspects of depression and anxiety. Each scale contains 7 questions to be answered on a 4-step Likert scale by the patients themselves. After inverting negative questions, higher scores mean a worse outcome.
Measured: Immediately pre-surgery to 3 months post-surgery
Number of participants with postoperative acute ischemic lesions at the time of discharge from the acute clinic as assessed by magnetic resonance images (MRI).
Cranial MRI will be performed using a 3-T scanner (Skyra; Siemens, Erlangen, Germany). The protocol of imaging will include a T2-weighted turbo spin-echo sequence, a T2-weighted turbo spin-echo sequence for dark fluid, a T1-weighted FLASH sequence and a diffusion-weighted echo-planar imaging sequence.
Measured: Once within the 6th-10th day immediately post-surgery
Number of participants with postoperative microemboli at the time of discharge from the acute clinic as assessed by magnetic resonance images (MRI).
Cranial MRI will be performed using a 3-T scanner (Skyra; Siemens, Erlangen, Germany). The protocol of imaging will include a T2-weighted turbo spin-echo sequence, a T2-weighted turbo spin-echo sequence for dark fluid, a T1-weighted FLASH sequence and a diffusion-weighted echo-planar imaging sequence.
Measured: Once within the 6th-10th day immediately post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start28 Feb 2019
- Primary completion19 Dec 2022
- Study completion19 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative DeliriumStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart and Brain Research Group, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Jünemann, Dr.med.M.Sc., Principal investigator, Clinic for Neurology, University Hospital GiessenMarius Butz, Dipl.-Psych., Principal investigator, Department of Cardiac Surgery, Kerckhoff Clinic Bad NauheimTibo Gerriets, Prof.Dr.med., Principal investigator, Department of Neurology, Gesundheitszentrum WetterauMarkus Schönburg, Prof.Dr.med., Principal investigator, Department of Cardiac Surgery, Kerckhoff Clinic Bad NauheimWon-Keun Kim, Dr.med., Principal investigator, Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535076
- Sponsor's protocol ID
- MC 68/2017
- Acronym
- COSTA
- Status last verified
- Mar 2022
- First submitted
- 27 Aug 2020
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Butz M, Juenemann M, El-Shazly J, Meyer R, Gerriets T, Braun T, Yenigun M, Schmidt H, Tschernatsch M, Schramm P, Alhaj-Omar O, Kirchhof A, Choi YH, Sossalla S, Renker M, Blankenberg S, Seiffert M, Schoenburg M, Kim WK. Neurocognition and health-related quality of life in patients randomized to surgical or transcatheter aortic-valve replacement. Clin Res Cardiol. 2026 Feb 5. doi: 10.1007/s00392-026-02862-1. Online ahead of print.
PubMed 41642336
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Outcome After Surgical and Transcatheter Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT04535076
- Acronym / sponsor ID
- COSTA / MC 68/2017
- Conditions
- Postoperative Delirium, Postoperative Cognitive Dysfunction, Transcatheter Aortic Valve Replacement, Surgical Aortic Valve Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Heart and Brain Research Group, GermanyUniversity, hospital or other
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 19 Dec 2022 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 1 Sep 2020 (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.
Aortic valve stenosis is one of the most common types of heart disease in the aging Western population. While surgical cardiac valve replacement (SAVR) is a standard therapy for patients with aortic stenosis, catheter-assisted aortic valve implantation (TAVI) has developed as an alternative to open-heart surgery, especially for high-risk patients. Recently, increased surgeon experience and improved transcatheter valve systems have led to a global trend to use TAVI in patients with low or intermediate risk. Although cognitive impairment after cardiac surgery is well known, the effect of TAVI on cognitive function has not yet been adequately investigated. The aim of this study is to compare the occurrence and progression of delirium, postoperative cognitive decline (POCD), cerebral infarction, and health-related quality of life (QOL) in patients with intermediate risk for catheter-assisted (TAVI) and surgical (SAVR) aortic valve replacement.
Detailed description
The present project is a substudy of the DEDICATE Trial (ID: NCT03112980). It is a randomized intervention study taking place at the Kerckhoff-Klink Bad Nauheim Germany (Campus Justus Liebig University Giessen) involving 100 patients undergoing aortic valve replacement (TAVI vs. SAVR) with a focus on cognitive outcome. A detailed assessment of psychological and health-related functions will be performed before intervention, during hospitalization and 3 months after intervention. During hospitalization, the occurrence and progression of delirium will be assessed with the Intensive Care Delirium Screening Checklist (ICDSC). Other cognitive data will be collected before and 3 months after surgery with a selected and comprehensive neuropsychological test battery, including the evaluation of attention, word fluency, executive functions and various functional areas of memory. In addition, parameters of health-related QOL will be collected before and 3 months after the intervention using the SF-36, and information on anxiety and depression will be collected using the Hospital Anxiety and Depression Scale (HADS). A few days after the intervention, magnetic resonance images of the brain will be acquired to assess cerebral infarction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcatheter Aortic Valve Implantation | Experimental | Procedure: Transcatheter Aortic Valve Implantation |
| Surgical Aortic Valve Replacement | Active comparator | Procedure: Surgical Aortic Valve Replacement |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (17 listed)
- Heart team decision that both TAVI and SAVR are medically justified based on
- Patient has agreed in writing to participate in the study
- Patient is able to understand the patient information and sign it personally
- Patient agrees to undergo SAVR if randomization into the control group occurs
- Readiness for MRT examination and neuropsychological testing after 3 months
Key exclusion criteria (13 listed)
- Congenital aortic valve defects
- Untreated clinically significant coronary artery disease or severe mitral or tricuspid insufficiency or mitral stenosis
- Previous heart surgery
- Percutaneous coronary intervention performed within one month prior to the study
- Hemodynamic instability requiring inotropic support or mechanical circulatory support
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 |
|---|---|---|
| Transcatheter Aortic Valve ImplantationTranscatheter Aortic Valve Implantation | Procedure or surgery | Transcatheter Aortic Valve Implantation |
| Surgical Aortic Valve ReplacementSurgical Aortic Valve Replacement | Procedure or surgery | Surgical Aortic Valve Replacement |
Primary outcome
Number of participants with postoperative cognitive decline at 3 months after surgery, defined as a decrease between pre- and postoperative examinations of one standard deviation in at least 20% of all objective neuropsychological parameters
Time frame: Immediately pre-surgery to 3 months post-surgery
The objective neuropsychological parameters measure cognitive domains like immediate memory span, free recall, recognition memory, selective attention, working memory, inhibition and word fluency. These cognitive domains will be measured with the following instruments: "Verbaler Lern- und Merkfähigkeitstest" (VLMT), "Trail Making Test A/B" (TMT), "Letter Number Span Test" (LNS), Block Tapping Test (BTT), "Regensburger Wortflüssigkeits-Test" (RWT), and "Syndrom-Kurz Test" (SKT).
Number of participants with postoperative cognitive decline at the time of discharge from the acute clinic, defined as a decrease between the pre- and postoperative examinations of one standard deviation measured with the "Montreal Cognitive Assessment"
Time frame: Immediately pre-surgery to approximately 1 week post-surgery
The "Montreal Cognitive Assessment" (MOCA) is a screening procedure for general cognitive function.
Number of participants with postoperative delirium during the stay in the intensive care unit as assessed by the "Intensive Care Delirium Screening Checklist" (ICDSC)
Time frame: Immediately post-surgery to approximately 7 days post-surgery
Postoperative delirium is defined as the occurrence of at least one delirious episode during a stay in the intensive care unit. The "Intensive Care Delirium Screening Checklist" (ICDSC) record the clinical symptoms of consciousness, attention, orientation, hallucinations, psychomotor retardation or agitation, speech, and changing symptoms by observing behavior and asking concrete questions to the patient.
6 secondary outcomes
Change from baseline cognitive failures in everyday life at 3 months after surgery as assessed by the "Cognitive Failures Questionnaire" (CFQ)
Time frame: Immediately pre-surgery to 3 months post-surgery
Change from baseline health-related quality of life at 3 months after surgery as assessed by the "36-Item Short Form Health Survey" (SF36)
Time frame: Immediately pre-surgery to 3 months post-surgery
Change from baseline anxiety at 3 months after surgery as assessed by the "Hospital Anxiety and Depression Scale" (HADS).
Time frame: Immediately pre-surgery to 3 months post-surgery
Change from baseline depression at 3 months after surgery as assessed by the "Hospital Anxiety and Depression Scale" (HADS).
Time frame: Immediately pre-surgery to 3 months post-surgery
Number of participants with postoperative acute ischemic lesions at the time of discharge from the acute clinic as assessed by magnetic resonance images (MRI).
Time frame: Once within the 6th-10th day immediately post-surgery
Number of participants with postoperative microemboli at the time of discharge from the acute clinic as assessed by magnetic resonance images (MRI).
Time frame: Once within the 6th-10th day immediately post-surgery
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 22 Sep 2023.
- Derived from this study: PubMed 41642336Butz M, Juenemann M, El-Shazly J, Meyer R, Gerriets T, Braun T, Yenigun M, Schmidt H, Tschernatsch M, Schramm P, Alhaj-Omar O, Kirchhof A, Choi YH, Sossalla S, Renker M, Blankenberg S, Seiffert M, Schoenburg M, Kim WK. Neurocognition and health-related quality of life in patients randomized to surgical or transcatheter aortic-valve replacement. Clin Res Cardiol. 2026 Feb 5. doi: 10.1007/s00392-026-02862-1. Online ahead of print.
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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.
Martin Jünemann, Dr.med.M.Sc. principal investigator
Clinic for Neurology, University Hospital Giessen
Marius Butz, Dipl.-Psych. principal investigator
Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim
Tibo Gerriets, Prof.Dr.med. principal investigator
Department of Neurology, Gesundheitszentrum Wetterau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement in people with Postoperative Delirium and Postoperative Cognitive Dysfunction, run by Heart and Brain Research Group, Germany 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 17 inclusion and 13 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 22 Sep 2023. 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?
Number of participants with postoperative cognitive decline at 3 months after surgery, defined as a decrease between pre- and postoperative examinations of one standard deviation in at least 20% of all objective neuropsychological parameters (time frame: Immediately pre-surgery to 3 months post-surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04535076, which also lists 1 linked publication.
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 22 Sep 2023; AzTrials last refreshed its copy on 6 Nov 2026.