Neurobehavioral ManifestationsNCT02306460
Frontal Cognitive Control Functions Before and After Percutaneous Catheter Procedures in Treatment of Atrial Fibrillation
An observational study of Neurobehavioral Manifestations and Atrial Fibrillation, run by Tampere University Hospital at 1 site in Finland.
Trial summary
Atrial fibrillation is a common arrythmia. It is an independent risk factor for stroke. There for anticoagulation therapy is used for atrial fibrillation patients. Alternatively, left atrial appendix closure can be used, if the risk for bleeding complications is deemed greater than the possible antithrombotic benefit… Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Neurobehavioral Manifestations, Atrial Fibrillation
- How many people
- 17 participants
- Where
- 1 siteFinland
- Study dates
- 9 Feb 2015to Dec 2020
- How long will I take part?
- 1 Year
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 80 patients will be drafted for the study. The subjects will be recruited from Tampere University Hospital Heart Hospital Co. Total of fifty patients, men and women between 50-70 years, undergoing left atrial catheter ablation (LACA) (30 patients) or percutaneous left atrial appendix closure procedure (20 patients) because of paroxysmal or persistent atrial fibrillation, will be recruited for the study. A control group of 15 patients with paroxysmal atrial fibrillation and 15 patients with persistent atrial fibrillation who are treated with antiarrhythmic and anticoagulation therapies suggested by current guidelines will be tested with the same testing schema and time points. Control group will be drafted from the cardiologic patients of the Heart Hospital and also from Hatanpää Hospital cardiologic outpatient clinic.
Who may be able to join
- age 50-70
- undergoing left atrial catheter ablation or percutaneous left atrial appendix closure procedure
- In the ablation group, patients will qualify for the study if they have symptomatic atrial fibrillation (EHRA classification 2-4) and if their risk of thromboembolic complications with CHA2DS2VASc scale is low (0-2 points).
Who cannot join
- Age under 18 or over 70 years.
- Contraindication for anticoagulation therapy (in ablation group),
- Previous neurological or psychiatric disorder.
- Significant visual problem that can't be corrected for,
- problems with upper arm/hand use, that would make the execution of the test difficult.
- normal contraindications for the ablation and appendix closure procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Atrial fibrillation is a common arrythmia. It is an independent risk factor for stroke. There for anticoagulation therapy is used for atrial fibrillation patients. Alternatively, left atrial appendix closure can be used, if the risk for bleeding complications is deemed greater than the possible antithrombotic benefit of anticoagulation medication. Up to 70% of ischemic complications can be prevented with anticoagulation therapy, and left atrial appendix closure seems to have comparable results. Also left atrial catherter ablation (LACA) is gaining popularity as a therapeutic intervention for atrial fibrillation.
However, the procedure is associated with 0,5-1% perioperative risk of clinically evident transient ischemic attack (TIA) or stroke. While the incidence of clinically evident ischemic complications remain relatively low, recent data suggest that 13%-20% of patients undergoing LACA are affected by post-operative neurocognitive dysfunction (POCD) 90 days after ablation.
The goal of the study is to improve detection of subtle brain dysfunction after cardiac interventions by employing an experimental executive reaction time (RT) test along with EEG recording in aims to improve objective detection of subtle brain dysfunction assumed to underlie persistent cognitive, somatic, and affective complaints reported by patients who have undergone atrial fibrillation ablation.
- Keywords
- Neurobehavioral Manifestations, POCD, Atrial Fibrillation, Anti-Arrhythmia, Atrial Appendage Closure
- Medical subject headings
- Neurobehavioral Manifestations, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| left atrial catheter ablation | Not described | |
| left atrial appendix closure | Not described | |
| paroxysmal atrial fibrillation control group | Not described | |
| persistent atrial fibrillation control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in response speeds (ms) and response error rate (%) in the executive RT-test
Measured: 1 day before procedure, 3 months and 1 year after post-procedure
Secondary outcomes (1)
Changes in amplitude of N2/P3 complex in the EEG recording
Measured: 1 day before procedure, 3 months and 1 year after post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study start9 Feb 2015
- Primary completionDec 2020
- Study completionDec 2020
Why it stopped: Changes in personnel
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurobehavioral ManifestationsStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kati Järvelä, Tampere University Hospital
- Investigators
- Kaisa Hartikainen, MD, Docent, Study director, Behavioral Neurology Research UnitKati Järvelä, MD, PhD, Study director, Tampere Heart HospitalArvi Yli-Hankala, MD, Professor, Study director, Tampere University HospitalJonne Liimatainen, MD, Principal investigator, Tampere University HospitalPekka Raatikainen, MD, Docent, Study director, Tampere Heart HospitalJaakko Inkovaara, MD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306460
- Sponsor's protocol ID
- R14068
- Status last verified
- Apr 2024
- First submitted
- 11 Jul 2014
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frontal Cognitive Control Functions Before and After Percutaneous Catheter Procedures in Treatment of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02306460
- Acronym / sponsor ID
- R14068
- Keywords
- Neurobehavioral Manifestations, POCD, Atrial Fibrillation, Anti-Arrhythmia, Atrial Appendage Closure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Changes in personnel
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 9 Feb 2015 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 3 Dec 2014 (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.
Atrial fibrillation is a common arrythmia. It is an independent risk factor for stroke. There for anticoagulation therapy is used for atrial fibrillation patients. Alternatively, left atrial appendix closure can be used, if the risk for bleeding complications is deemed greater than the possible antithrombotic benefit of anticoagulation medication. Up to 70% of ischemic complications can be prevented with anticoagulation therapy, and left atrial appendix closure seems to have comparable results. Also left atrial catherter ablation (LACA) is gaining popularity as a therapeutic intervention for atrial fibrillation.
However, the procedure is associated with 0,5-1% perioperative risk of clinically evident transient ischemic attack (TIA) or stroke. While the incidence of clinically evident ischemic complications remain relatively low, recent data suggest that 13%-20% of patients undergoing LACA are affected by post-operative neurocognitive dysfunction (POCD) 90 days after ablation.
The goal of the study is to improve detection of subtle brain dysfunction after cardiac interventions by employing an experimental executive reaction time (RT) test along with EEG recording in aims to improve objective detection of subtle brain dysfunction assumed to underlie persistent cognitive, somatic, and affective complaints reported by patients who have undergone atrial fibrillation ablation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| left atrial catheter ablation | – | – |
| left atrial appendix closure | – | – |
| paroxysmal atrial fibrillation control group | – | – |
| persistent atrial fibrillation control group | – | – |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 80 patients will be drafted for the study. The subjects will be recruited from Tampere University Hospital Heart Hospital Co. Total of fifty patients, men and women between 50-70 years, undergoing left atrial catheter ablation (LACA) (30 patients) or percutaneous left atrial appendix closure procedure (20 patients) because of paroxysmal or persistent atrial fibrillation, will be recruited for the study. A control group of 15 patients with paroxysmal atrial fibrillation and 15 patients with persistent atrial fibrillation who are treated with antiarrhythmic and anticoagulation therapies suggested by current guidelines will be tested with the same testing schema and time points. Control group will be drafted from the cardiologic patients of the Heart Hospital and also from Hatanpää Hospital cardiologic outpatient clinic.
Key inclusion criteria (3 listed)
- age 50-70
- undergoing left atrial catheter ablation or percutaneous left atrial appendix closure procedure
- In the ablation group, patients will qualify for the study if they have symptomatic atrial fibrillation (EHRA classification 2-4) and if their risk of thromboembolic complications with CHA2DS2VASc scale is low (0-2 points).
Key exclusion criteria (6 listed)
- Age under 18 or over 70 years.
- Contraindication for anticoagulation therapy (in ablation group),
- Previous neurological or psychiatric disorder.
- Significant visual problem that can't be corrected for,
- problems with upper arm/hand use, that would make the execution of the test difficult.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in response speeds (ms) and response error rate (%) in the executive RT-test
Time frame: 1 day before procedure, 3 months and 1 year after post-procedure
1 secondary outcome
Changes in amplitude of N2/P3 complex in the EEG recording
Time frame: 1 day before procedure, 3 months and 1 year after post-procedure
Results and safety
The study was stopped early (reason given: Changes in personnel). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
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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.
Kaisa Hartikainen, MD, Docent study director
Behavioral Neurology Research Unit
Kati Järvelä, MD, PhD study director
Tampere Heart Hospital
Arvi Yli-Hankala, MD, Professor study director
Tampere University Hospital
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 Neurobehavioral Manifestations and Atrial Fibrillation, run by Tampere University Hospital at 1 site in Finland.
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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 10 Apr 2024. 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 Finland. 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 was stopped early (reason given: Changes in personnel). Results are not available in the source record.
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?
Changes in response speeds (ms) and response error rate (%) in the executive RT-test (time frame: 1 day before procedure, 3 months and 1 year after post-procedure). 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 10 Apr 2024; AzTrials last refreshed its copy on 30 Oct 2026.