Electrical Cardioversion of Atrial Fibrillation Clinical Trial
| NCT number | NCT02378155 |
| Other study ID # | AF I |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | December 17, 2014 |
| Last updated | August 18, 2015 |
| Start date | February 2015 |
| Verified date | August 2015 |
| Source | Hasselt University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Belgium: Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Ziekenhuis Oost-Limburg | Genk | Limburg |
| Lead Sponsor | Collaborator |
|---|---|
| Hasselt University |
Belgium,
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. Review. — View Citation
Wutzler A, Nee J, Boldt LH, Kühnle Y, Gräser S, Schröder 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Measure the cerebral saturation changes in response to electrical/pharmacological cardioversion | 6 months | No | |
| Secondary | Measure the time for recuperation of cerebral saturation after a period of decreased cerebral saturation | 6 months | No | |
| Secondary | Relate the responses of cerebral saturation, regional saturation, pulse oximetry and blood pressure with each other | 6 months | No | |
| Secondary | Compare the changes in cerebral oxygen saturation with the left ventricular ejection fraction | 6 months | No | |
| Secondary | Perform neuropsychological tests before and after electrical/pharmacological cardioversion | 6 months | No | |
| Secondary | Compare the response of the cerebral/regional saturation with the effects on the neurocognitive status | 6 months | No | |
| Secondary | Compare the response of the pulse oximetry with the effects on the neurocognitive status | 6 months | No | |
| Secondary | Compare the response of the blood pressure with the effects on the neurocognitive status | 6 months | No |