Aortic Valve StenosisINSERTNCT01251328
Near INfrared Spectroscopy in Aortic valvE ReplacemenT
A study testing General anaesthesia and Sedation in people with Aortic Valve Stenosis and Transcatheter Aortic Valve Implantation, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
Trial summary
Transcatheter aortic valve implantation (TAVI) is an alternative for patients, that are considered to be too sick for conventional aortic valve replacement. There is no conclusive opinion about the best anesthesiologic management of these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation, Eligibility for Both Anaesthetic Methods
- What is being tested?
- General anaesthesia and Sedation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2010to Apr 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed consent
- transcatheter aortic valve implantation
Who cannot join
- denial by patient
- denial by screening anaesthesist
- active neurodegenerative disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Near Infrared Spectroscopy in Aortic Valve Replacement
Transcatheter aortic valve implantation (TAVI) is an alternative for patients, that are considered to be too sick for conventional aortic valve replacement. There is no conclusive opinion about the best anesthesiologic management of these patients. Sedation and general anaesthesia are both adequate and the current literature shows no benefit towards one of these methods.
This study wants to investigate the influence of these two anesthesiologic managements on the cerebral oxygen saturation during the "rapid pacing"-period during valvuloplasty. The patients are randomised allocated to one of these two anaesthesiological managements. The investigators use the Near-Infrared Spectroscopy (NIRS) to measure the cerebral oxygen saturation. Parallel there will be a measurement of cerebral biomarkers to monitor cerebral hypoxia.
- Conditions
- Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation, Eligibility for Both Anaesthetic Methods
- Being tested
- General anaesthesia, Sedation
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anaesthesiaProcedure or surgery
general anaesthesia is performed according to the hospitals standard
SedationProcedure or surgery
Sedation is performed according to the hospitals standard
| Study group | Role | What they receive |
|---|---|---|
| General anaesthesia | Active comparator | General anaesthesia is performed under standardized conditions Receives: Procedure: General anaesthesia |
| Sedation | Active comparator | Sedation is performed under standardized conditions Receives: Procedure: Sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral oxygen desaturation during the "rapid pacing" period and periprocedural
Biomarkers for cerebral ischemia will be measured up to 48 hours
Measured: up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionApr 2012
- Study completionApr 2012
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, N Patrick Mayr, Deutsches Herzzentrum Muenchen
- Investigators
- Patrick N Mayr, MD, Principal investigator, Deutsches Herzzentrum München, Department of Anaesthesiology, Technische Universität München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251328
- Sponsor's protocol ID
- GE DHM-AN-OR-2010/01
- Acronym
- INSERT
- Status last verified
- Feb 2015
- First submitted
- 29 Nov 2010
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Mayr NP, Hapfelmeier A, Martin K, Kurz A, van der Starre P, Babik B, Mazzitelli D, Lange R, Wiesner G, Tassani-Prell P. Comparison of sedation and general anaesthesia for transcatheter aortic valve implantation on cerebral oxygen saturation and neurocognitive outcomedagger. Br J Anaesth. 2016 Jan;116(1):90-9. doi: 10.1093/bja/aev294. Epub 2015 Sep 29.
PubMed 26424178
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near Infrared Spectroscopy in Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT01251328
- Acronym / sponsor ID
- INSERT / GE DHM-AN-OR-2010/01
- Conditions
- Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation, Eligibility for Both Anaesthetic Methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 1 Dec 2010 (estimated)
- 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.
Transcatheter aortic valve implantation (TAVI) is an alternative for patients, that are considered to be too sick for conventional aortic valve replacement. There is no conclusive opinion about the best anesthesiologic management of these patients. Sedation and general anaesthesia are both adequate and the current literature shows no benefit towards one of these methods.
This study wants to investigate the influence of these two anesthesiologic managements on the cerebral oxygen saturation during the "rapid pacing"-period during valvuloplasty. The patients are randomised allocated to one of these two anaesthesiological managements. The investigators use the Near-Infrared Spectroscopy (NIRS) to measure the cerebral oxygen saturation. Parallel there will be a measurement of cerebral biomarkers to monitor cerebral hypoxia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General anaesthesia | Active comparator | Procedure: General anaesthesiaGeneral anaesthesia is performed under standardized conditions |
| Sedation | Active comparator | Procedure: SedationSedation is performed under standardized conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- informed consent
- transcatheter aortic valve implantation
Key exclusion criteria (3 listed)
- denial by patient
- denial by screening anaesthesist
- active neurodegenerative disease
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 |
|---|---|---|
| General anaesthesiageneral anaesthesia is performed according to the hospitals standard | Procedure or surgery | General anaesthesia |
| SedationSedation is performed according to the hospitals standard | Procedure or surgery | Sedation |
Primary outcome
Cerebral oxygen desaturation during the "rapid pacing" period and periprocedural
Time frame: up to 48 hours
Biomarkers for cerebral ischemia will be measured up to 48 hours
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 10 Feb 2015.
- Derived from this study: PubMed 26424178Mayr NP, Hapfelmeier A, Martin K, Kurz A, van der Starre P, Babik B, Mazzitelli D, Lange R, Wiesner G, Tassani-Prell P. Comparison of sedation and general anaesthesia for transcatheter aortic valve implantation on cerebral oxygen saturation and neurocognitive outcomedagger. Br J Anaesth. 2016 Jan;116(1):90-9. doi: 10.1093/bja/aev294. Epub 2015 Sep 29.
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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.
Patrick N Mayr, MD principal investigator
Deutsches Herzzentrum München, Department of Anaesthesiology, Technische Universität München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General anaesthesia and Sedation in people with Aortic Valve Stenosis and Transcatheter Aortic Valve Implantation, run by Deutsches Herzzentrum Muenchen 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 2 inclusion and 3 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 10 Feb 2015. 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?
Cerebral oxygen desaturation during the "rapid pacing" period and periprocedural (time frame: up to 48 hours). 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 NCT01251328, 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 10 Feb 2015; AzTrials last refreshed its copy on 4 Nov 2026.