Electrical Cardioversion of Atrial FibrillationNCT02378155
Cerebral Oxygen Saturation Measurement During Cardioversion Because of Atrial Fibrillation
A study testing SenSmart Model X-100, Nonin Medical in people with Electrical Cardioversion of Atrial Fibrillation and Pharmacological Cardioversion of Atrial Fibrillation, run by Hasselt University at 1 site in Belgium.
Trial summary
Near infrared spectroscopy (NIRS) is a technique that measures regional cerebral oxygenation in a non-invasive manner. Through the use of near infrared light, the difference between oxygenated and deoxygenated hemoglobin can be measured. By applying the Lambert-Beer law, a numeric result can be calculated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Electrical Cardioversion of Atrial Fibrillation, Pharmacological Cardioversion of Atrial Fibrillation
- What is being tested?
- SenSmart Model X-100, Nonin Medical
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2015to Jun 2015
- 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
- older than 18 years and able to give informed consent
- diagnosis of paroxysmal or persistent atrial fibrillation
- scheduled for electrical cardioversion or atrial fibrillation development in the first days after cardiac surgery followed by pharmacological treatment with amiodarone
- Dutch speaking
Who cannot join
- younger than 18 years or not able to give informed consent
- diagnosis of permanent atrial fibrillation
- atrial fibrillation with thrombus in left atrial appendage
- chronic obstructive pulmonary disease GOLD class 3 or 4
- airway manipulation during cardioversion
- pregnant women
- medical history of cerebrovascular accident or brain injury
- medical history of cardiopulmonary resuscitation
Trial locations and contacts
1 site in 1 country.
About this study
Near infrared spectroscopy (NIRS) is a technique that measures regional cerebral oxygenation in a non-invasive manner. Through the use of near infrared light, the difference between oxygenated and deoxygenated hemoglobin can be measured. By applying the Lambert-Beer law, a numeric result can be calculated.
Since atrial fibrillation (AF) has been linked with an increased risk for the development of neurocognitive deficits, a longer period of AF might be associated with a higher risk for neurocognitive deficits.
It is hypothesized that there is an increase in the regional cerebral oxygen saturation (rSO2) of patients with paroxysmal or persistent AF after successful cardioversion.
Read the detailed description
Written informed consent by the patient is asked before cardioversion and participation in the study. Patient anamnesis is assessed by standardized questionnaire.
Patients perform several standardised neurocognitive tests to obtain a general view on the neurocognitive status (auditory verbal learning test, mini-mental state examination, trail making A and B, digit-symbol coding and RAND 36 Health Survey).
Cerebral oxygenation is observed during cardioversion by means of the SenSmart Model X-100 (Nonin). Additional parameters (pulse oximetry, cardiac output, arterial blood pressure, 6-lead electrocardiography (ECG), left ventricular ejection fraction) are recorded. All measurements are performed non-invasively. Patients receive standard treatment following the clinical guidelines.
- Conditions
- Electrical Cardioversion of Atrial Fibrillation, Pharmacological Cardioversion of Atrial Fibrillation
- Being tested
- SenSmart Model X-100, Nonin Medical
- Keywords
- cardioversion, atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SenSmart Model X-100, Nonin MedicalDevice
Device to measure cerebral tissue oxygen saturation
| Study group | Role | What they receive |
|---|---|---|
| electrical cardioversion | Other | Hemodynamic unstable patients with atrial fibrillation who are scheduled to undergo electrical reconversion to convert their irregular heart rhythm into a normal sinus rhythm. Cerebral tissue oxygen saturation is measured by means of SenSmart Model X-100, Nonin Medical. Receives: Device: SenSmart Model X-100, Nonin Medical |
| pharmacological cardioversion | Other | Patients who develop atrial fibrillation after cardiac surgery. Pharmacological treatment with amiodarone is started in order to convert their irregular heart rhythm into a normal sinus rhythm. Cerebral tissue oxygen saturation is measured by means of SenSmart Model X-100, Nonin Medical. Receives: Device: SenSmart Model X-100, Nonin Medical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the cerebral saturation changes in response to electrical/pharmacological cardioversion
Measured: 6 months
Secondary outcomes (7)
Measure the time for recuperation of cerebral saturation after a period of decreased cerebral saturation
Measured: 6 months
Relate the responses of cerebral saturation, regional saturation, pulse oximetry and blood pressure with each other
Measured: 6 months
Compare the changes in cerebral oxygen saturation with the left ventricular ejection fraction
Measured: 6 months
Perform neuropsychological tests before and after electrical/pharmacological cardioversion
Measured: 6 months
Compare the response of the cerebral/regional saturation with the effects on the neurocognitive status
Measured: 6 months
Compare the response of the pulse oximetry with the effects on the neurocognitive status
Measured: 6 months
Compare the response of the blood pressure with the effects on the neurocognitive status
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Electrical Cardioversion of Atrial FibrillationStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cornelia Genbrugge, Hasselt University
- Investigators
- Cornelia Genbrugge, MD, Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378155
- Sponsor's protocol ID
- AF I
- Status last verified
- Aug 2015
- First submitted
- 17 Dec 2014
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Pellicer A, Bravo Mdel C. Near-infrared spectroscopy: a methodology-focused review. Semin Fetal Neonatal Med. 2011 Feb;16(1):42-9. doi: 10.1016/j.siny.2010.05.003. Epub 2010 Jun 26.
PubMed 20580625Wutzler A, Nee J, Boldt LH, Kuhnle Y, Graser S, Schroder T, Haverkamp W, Storm C. Improvement of cerebral oxygen saturation after successful electrical cardioversion of atrial fibrillation. Europace. 2014 Feb;16(2):189-94. doi: 10.1093/europace/eut246. Epub 2013 Jul 31.
PubMed 23902651
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Oxygen Saturation Measurement During Cardioversion Because of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02378155
- Acronym / sponsor ID
- AF I
- Conditions
- Electrical Cardioversion of Atrial Fibrillation, Pharmacological Cardioversion of Atrial Fibrillation
- Keywords
- cardioversion, atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jun 2015 (actual)
- First posted
- 4 Mar 2015 (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.
Near infrared spectroscopy (NIRS) is a technique that measures regional cerebral oxygenation in a non-invasive manner. Through the use of near infrared light, the difference between oxygenated and deoxygenated hemoglobin can be measured. By applying the Lambert-Beer law, a numeric result can be calculated.
Since atrial fibrillation (AF) has been linked with an increased risk for the development of neurocognitive deficits, a longer period of AF might be associated with a higher risk for neurocognitive deficits.
It is hypothesized that there is an increase in the regional cerebral oxygen saturation (rSO2) of patients with paroxysmal or persistent AF after successful cardioversion.
Detailed description
Written informed consent by the patient is asked before cardioversion and participation in the study. Patient anamnesis is assessed by standardized questionnaire.
Patients perform several standardised neurocognitive tests to obtain a general view on the neurocognitive status (auditory verbal learning test, mini-mental state examination, trail making A and B, digit-symbol coding and RAND 36 Health Survey).
Cerebral oxygenation is observed during cardioversion by means of the SenSmart Model X-100 (Nonin). Additional parameters (pulse oximetry, cardiac output, arterial blood pressure, 6-lead electrocardiography (ECG), left ventricular ejection fraction) are recorded. All measurements are performed non-invasively. Patients receive standard treatment following the clinical guidelines.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electrical cardioversion | Other | Device: SenSmart Model X-100, Nonin MedicalHemodynamic unstable patients with atrial fibrillation who are scheduled to undergo electrical reconversion to convert their irregular heart rhythm into a normal sinus rhythm. Cerebral tissue oxygen saturation is measured by means of SenSmart Model X-100, Nonin Medical. |
| pharmacological cardioversion | Other | Device: SenSmart Model X-100, Nonin MedicalPatients who develop atrial fibrillation after cardiac surgery. Pharmacological treatment with amiodarone is started in order to convert their irregular heart rhythm into a normal sinus rhythm. Cerebral tissue oxygen saturation is measured by means of SenSmart Model X-100, Nonin Medical. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- older than 18 years and able to give informed consent
- diagnosis of paroxysmal or persistent atrial fibrillation
- scheduled for electrical cardioversion or atrial fibrillation development in the first days after cardiac surgery followed by pharmacological treatment with amiodarone
- Dutch speaking
Key exclusion criteria (8 listed)
- younger than 18 years or not able to give informed consent
- diagnosis of permanent atrial fibrillation
- atrial fibrillation with thrombus in left atrial appendage
- chronic obstructive pulmonary disease GOLD class 3 or 4
- airway manipulation during cardioversion
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 |
|---|---|---|
| SenSmart Model X-100, Nonin MedicalDevice to measure cerebral tissue oxygen saturation | Device | electrical cardioversion, pharmacological cardioversion |
Primary outcome
Measure the cerebral saturation changes in response to electrical/pharmacological cardioversion
Time frame: 6 months
7 secondary outcomes
Measure the time for recuperation of cerebral saturation after a period of decreased cerebral saturation
Time frame: 6 months
Relate the responses of cerebral saturation, regional saturation, pulse oximetry and blood pressure with each other
Time frame: 6 months
Compare the changes in cerebral oxygen saturation with the left ventricular ejection fraction
Time frame: 6 months
Perform neuropsychological tests before and after electrical/pharmacological cardioversion
Time frame: 6 months
Compare the response of the cerebral/regional saturation with the effects on the neurocognitive status
Time frame: 6 months
Compare the response of the pulse oximetry with the effects on the neurocognitive status
Time frame: 6 months
Compare the response of the blood pressure with the effects on the neurocognitive status
Time frame: 6 months
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 19 Aug 2015.
- Background: PubMed 20580625Pellicer A, Bravo Mdel C. Near-infrared spectroscopy: a methodology-focused review. Semin Fetal Neonatal Med. 2011 Feb;16(1):42-9. doi: 10.1016/j.siny.2010.05.003. Epub 2010 Jun 26.
- Background: PubMed 23902651Wutzler A, Nee J, Boldt LH, Kuhnle Y, Graser S, Schroder T, Haverkamp W, Storm C. Improvement of cerebral oxygen saturation after successful electrical cardioversion of atrial fibrillation. Europace. 2014 Feb;16(2):189-94. doi: 10.1093/europace/eut246. Epub 2013 Jul 31.
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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.
Cornelia Genbrugge, MD principal investigator
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SenSmart Model X-100, Nonin Medical in people with Electrical Cardioversion of Atrial Fibrillation and Pharmacological Cardioversion of Atrial Fibrillation, run by Hasselt University at 1 site in Belgium.
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 8 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 19 Aug 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 Belgium. 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?
Measure the cerebral saturation changes in response to electrical/pharmacological cardioversion (time frame: 6 months). 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 NCT02378155, which also lists 2 linked publications.
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 19 Aug 2015.