Atrial FibrillationODEA-TIANCT04075500
Optimal Detection of Atrial Fibrillation in TIA
A study testing Subcutaneously implanted event recorder (REVEAL LINQ) and 28-day non-invasive continuous ECG monitoring (patch) in people with Atrial Fibrillation and Transient Ischemic Attack, run by Alfried Krupp Krankenhaus at 27 sites in 2 countries.
Trial summary
Transient ischemic attack (TIA) is a common neurologic emergency. Although the detection of atrial fibrillation (AF) has identical consequences for preventive therapy in patients with ischemic stroke and TIA, the management setting and diagnostic pathways frequently differ substantially between both manifestations. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Atrial Fibrillation, Transient Ischemic Attack
- What is being tested?
- Subcutaneously implanted event recorder (REVEAL LINQ) and 28-day non-invasive continuous ECG monitoring (patch)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 516 participants
- Where
- 27 sitesin 2 countries
- Study dates
- 12 Mar 2019to 31 Aug 2025
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent by patient.
- Age ≥ 50 years.
- TIA diagnosed by a stroke physician defined as rapidly developing clinical signs of focal or global disturbances of cerebral function, lasting less than 24 hours with no apparent non-vascular cause
- 12-channel ECG available before enrolment
- Brain imaging available before enrolment (CCT or cranial MRI)
- Vascular imaging of cervical vessels performed
Show all 16Show fewer
- Enrolment within 28 days after TIA episode. Exclusion Criteria
- Previously documented history of AF
- Ischemic stroke within the last 6 months before enrolment
- Pre-screening monitoring for cardiac arrhythmias lasting ≥72 hours
- AF lasting > 30 s on a 12 channel ECG or other ECG recording technique prior to enrolment
- Life expectancy less than 1 year.
- Significant stenosis > 50% in intracranial or extracranial vessels which, in the opinion of the investigator, is the likely cause of the patients TIA.
- Severely disabled patients (i.e. modified Rankin Score >3)
- Lack of therapeutic consequence in case of diagnosis of AF (e.g. other indication for long term anticoagulation
- Pacemaker or Implanted Cardiac Defibrillator
Who cannot join
None listed.
Trial locations and contacts
27 sites in 2 countries.
27 sites in 2 countries
Germany16 sites
Universitätsklinikum Aachen, Neurologie
Aachen, 52074
Rhön Klinikum Campus Bad Neustadt
Bad Neustadt an der Saale, 97616
Vivantes Klinikum Neukölln
Berlin, 12351
Carl-Thiem-Klinikum Cottbus; Klinik für Neurologie
Cottbus, 03048
Klinikum Dortmund, Klinikzentrum Mitte / Neurologie
Dortmund, 44137
Alfried Krupp Krankenhaus
Essen, 45131
Universitätsmedizin Frankfurt; Klinik für Neurologie;
Frankfurt, 60590
Bezirkskliniken Schwaben; Bezirkskrankenhaus Günzburg; Klinik für Neurologie
Günzburg, 89312
Krankenhaus Marth-Maria-Halle-Dölau GmbH; Klinik für Neurologie
Halle, 06120
Universitätsmedizin Halle; Universitätsklinikum Halle (Saale); Klinik und Poliklinik für Neurologie
Halle, 06120
Universitätsklinik Heidelberg, Neurologie
Heidelberg, 69120
Universität Leipzig, Medizinische Fakultät; Klinik und Poliklinik für Neurologie
Leipzig, 04103
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, 23538
Universitätsklinikum Tübingen; Neurologische Universitätsklinik; Abt. Neurologie mit Schwerpunkt vaskuläre Erkrankungen
Tübingen, 72076
RKU Universitäts- und Rehabilitationskliniken Ulm
Ulm, 89081
Universitätsklinikum Würzburg
Würzburg, 97080
Spain11 sites
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006
Hospital Universitario Torrecárdenas
Almería, 04009
Hospital Germans Trias i Pujol
Badalona, 08916
Hospital Universitario de Cruces
Barakaldo, Bizkaia, 48903
Hospital del Mar
Barcelona, 08003
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Hospital Universitario Reina Sofia
Córdoba, 14011
Hospital Dr. Josep Trueta
Girona, 17007
Complejo Hospitalario Clinico Universitario de Santiago
Santiago de Compostela, 15706
Hospital Universitario Virgen del Rocio
Seville, 41003
Hospital Virgen Macarena
Seville, 41009
About this study
Official title: Optimal Detection of Atrial Fibrillation in Transient Ischemic Attack
Transient ischemic attack (TIA) is a common neurologic emergency. Although the detection of atrial fibrillation (AF) has identical consequences for preventive therapy in patients with ischemic stroke and TIA, the management setting and diagnostic pathways frequently differ substantially between both manifestations. Despite these differences between stroke and TIA patients, previous studies have investigated diagnostic work-up for AF primarily in stroke patients. Thus, there is no common practice or "gold standard" of rhythm monitoring for TIA patients in most healthcare systems and the optimal method and duration of cardiac monitoring for TIA patients is currently unknown. This is likely to result in a substantial under-diagnosis of AF in TIA patients, failure to initiate appropriate secondary preventive medication (i.e. anticoagulation) and ultimately the occurrence of many otherwise preventable strokes.
The primary research question of the trial is whether prolonged ECG recording using a subcutaneously implanted event recorder increases the detection rate of paroxysmal AF (pAF) within 6 months after the event in patients with recent TIA both compared to 24-h ECG recording and compared to prolonged ECG recording using non-invasive continuous ECG recording for 28 days AND To determine whether 28-day non-invasive ECG monitoring increases the detection rate of pAF within 6 months after the event compared to 24-h ECG recording.
Read the detailed description
Transient ischemic attacks (TIA) are a common neurologic emergency. Clinical management guidelines recommend oral anticoagulation for TIA patients suffering from atrial fibrillation (AF). Therefore, a diagnosis of AF in TIA patients has a major impact on the choice of adequate secondary stroke prevention. However, detection of paroxysmal AF in patients with TIA can be challenging. AF remains undetected in a relevant proportion of stroke and TIA patients using current routine diagnostic procedures. The actual prevalence of AF in TIA patients is unknown.
Although the detection of AF has identical consequences for preventive therapy in patients with ischemic stroke and TIA, the management setting and diagnostic pathways frequently differ substantially between both manifestations. So far, only limited data exist on AF detection after TIA specifically, and the best method for diagnosis of AF has not been established. The usefulness of prolonged rhythm monitoring using event recorders or non-invasive continuous ECG in TIA patients has not been determined. While the use of an AF detection tool in TIA patients is desirable, an adequate use of resources of AF detection technologies in unselected TIA patients may be needed for this large scale health care problem. Identifying TIA patients that are at increased risk of suffering from AF using clinical and blood-based biomarkers and therefore most likely to benefit from such diagnostic procedures would be useful.
The primary research question of the trial is whether prolonged ECG recording using a subcutaneously implanted event recorder increases the detection rate of paroxysmal AF (pAF) within 6 months after the event in patients with recent TIA both compared to 24-h ECG recording and compared to prolonged ECG recording using non-invasive continuous ECG recording for 28 days AND To determine whether 28-day non-invasive ECG monitoring increases the detection rate of pAF within 6 months after the event compared to 24-h ECG recording. The ODEA-TIA trial is an investigator initiated prospective, multicentre, randomized, open study with blinded outcome assessment comparing different diagnostic methods for detection of paroxysmal AF in patients with recent TIA. The primary endpoint is the rate of AF detection during the 6 months after randomization. Approximately 40 centers in Europe (Germany and Spain) will participate in this trial. Patients with a recent TIA fulfilling the eligibility criteria (see below) will be randomized in a 1:1:1 fashion between 24 h arrhythmia monitoring (control arm) and the two procedures for prolonged ECG monitoring (interventional arms). That means we have two interventional arms, patients receiving either continuous 28d non-invasive ECG monitoring or ECG event recording using a subcutaneously implanted event recorder.
- Conditions
- Atrial Fibrillation, Transient Ischemic Attack
- Being tested
- Subcutaneously implanted event recorder (REVEAL LINQ), 28-day non-invasive continuous ECG monitoring (patch)
- Keywords
- atrial fibrillation, monitoring, ECG, ischemic attack
- Medical subject headings
- Atrial Fibrillation, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneously implanted event recorder (REVEAL LINQ)Device
Patients receive a subcutaneously implantable cardiac device (REVEAL LINQ).
28-day non-invasive continuous ECG monitoring (patch)Device
Patients receive a non-invasive continuous ECG monitoring (patch)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | No intervention | Control arm, 24-h Holter monitoring |
| Arm 2 | Other | 1st interventional arm, subcutaneously implanted event recorder (REVEAL LINQ) Receives: Device: Subcutaneously implanted event recorder (REVEAL LINQ) |
| Arm 3 | Other | 2nd interventional arm, 28-day continuous ECG monitoring Receives: Device: 28-day non-invasive continuous ECG monitoring (patch) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of newly detected AF at 6 month after study enrolment in patients with recent TIA
Self reported or by other means detected newly AF
Measured: 6 month
Secondary outcomes (2)
Prevalence of AF in TIA patients as determined by prolongend ECG Monitoring techniques
Self reported or by other means detected newly AF
Measured: 24 month
Rate of newly detected AF at 12 and 24 month after study enrolment in patients with recent TIA
Self reported or by other means detected newly AF in longterm ECG Monitoring
Measured: 12 and 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start12 Mar 2019
- Primary completion15 Mar 2024
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patient will be randomized to either receive 24-h Holter Monitoring or receive one of the two modes for prolonged ECG recording (interventional arms). Patient will either undergo 28-day ECG recording using a commercially available Holter Recorder that can function as a non-invasive ECG patch or receive an implantable cardiac device (REVEAL LINQ).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 516 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alfried Krupp Krankenhaus
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic Bakken Research, Coordinating Centre for Clinical Trials Heidelberg, Wuerzburg University Hospital
- Responsible party
- Sponsor
- Investigators
- Roland Veltkamp, MD, Principal investigator, Initiator of study, leader PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075500
- Sponsor's protocol ID
- AKKNeuro2019July
- Acronym
- ODEA-TIA
- Status last verified
- Feb 2026
- First submitted
- 28 Aug 2019
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Detection of Atrial Fibrillation in Transient Ischemic Attack
- ClinicalTrials.gov ID
- NCT04075500
- Acronym / sponsor ID
- ODEA-TIA / AKKNeuro2019July
- Conditions
- Atrial Fibrillation, Transient Ischemic Attack
- Keywords
- atrial fibrillation, monitoring, ECG, ischemic attack
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- Alfried Krupp KrankenhausUniversity, hospital or other
- Collaborators
- Medtronic Bakken Research, Coordinating Centre for Clinical Trials Heidelberg, Wuerzburg University Hospital
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 30 Aug 2019 (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.
Transient ischemic attack (TIA) is a common neurologic emergency. Although the detection of atrial fibrillation (AF) has identical consequences for preventive therapy in patients with ischemic stroke and TIA, the management setting and diagnostic pathways frequently differ substantially between both manifestations. Despite these differences between stroke and TIA patients, previous studies have investigated diagnostic work-up for AF primarily in stroke patients. Thus, there is no common practice or "gold standard" of rhythm monitoring for TIA patients in most healthcare systems and the optimal method and duration of cardiac monitoring for TIA patients is currently unknown. This is likely to result in a substantial under-diagnosis of AF in TIA patients, failure to initiate appropriate secondary preventive medication (i.e. anticoagulation) and ultimately the occurrence of many otherwise preventable strokes.
The primary research question of the trial is whether prolonged ECG recording using a subcutaneously implanted event recorder increases the detection rate of paroxysmal AF (pAF) within 6 months after the event in patients with recent TIA both compared to 24-h ECG recording and compared to prolonged ECG recording using non-invasive continuous ECG recording for 28 days AND To determine whether 28-day non-invasive ECG monitoring increases the detection rate of pAF within 6 months after the event compared to 24-h ECG recording.
Detailed description
Transient ischemic attacks (TIA) are a common neurologic emergency. Clinical management guidelines recommend oral anticoagulation for TIA patients suffering from atrial fibrillation (AF). Therefore, a diagnosis of AF in TIA patients has a major impact on the choice of adequate secondary stroke prevention. However, detection of paroxysmal AF in patients with TIA can be challenging. AF remains undetected in a relevant proportion of stroke and TIA patients using current routine diagnostic procedures. The actual prevalence of AF in TIA patients is unknown.
Although the detection of AF has identical consequences for preventive therapy in patients with ischemic stroke and TIA, the management setting and diagnostic pathways frequently differ substantially between both manifestations. So far, only limited data exist on AF detection after TIA specifically, and the best method for diagnosis of AF has not been established. The usefulness of prolonged rhythm monitoring using event recorders or non-invasive continuous ECG in TIA patients has not been determined. While the use of an AF detection tool in TIA patients is desirable, an adequate use of resources of AF detection technologies in unselected TIA patients may be needed for this large scale health care problem. Identifying TIA patients that are at increased risk of suffering from AF using clinical and blood-based biomarkers and therefore most likely to benefit from such diagnostic procedures would be useful.
The primary research question of the trial is whether prolonged ECG recording using a subcutaneously implanted event recorder increases the detection rate of paroxysmal AF (pAF) within 6 months after the event in patients with recent TIA both compared to 24-h ECG recording and compared to prolonged ECG recording using non-invasive continuous ECG recording for 28 days AND To determine whether 28-day non-invasive ECG monitoring increases the detection rate of pAF within 6 months after the event compared to 24-h ECG recording. The ODEA-TIA trial is an investigator initiated prospective, multicentre, randomized, open study with blinded outcome assessment comparing different diagnostic methods for detection of paroxysmal AF in patients with recent TIA. The primary endpoint is the rate of AF detection during the 6 months after randomization. Approximately 40 centers in Europe (Germany and Spain) will participate in this trial. Patients with a recent TIA fulfilling the eligibility criteria (see below) will be randomized in a 1:1:1 fashion between 24 h arrhythmia monitoring (control arm) and the two procedures for prolonged ECG monitoring (interventional arms). That means we have two interventional arms, patients receiving either continuous 28d non-invasive ECG monitoring or ECG event recording using a subcutaneously implanted event recorder.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Patient will be randomized to either receive 24-h Holter Monitoring or receive one of the two modes for prolonged ECG recording (interventional arms). Patient will either undergo 28-day ECG recording using a commercially available Holter Recorder that can function as a non-invasive ECG patch or receive an implantable cardiac device (REVEAL LINQ).
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | No intervention | –Control arm, 24-h Holter monitoring |
| Arm 2 | Other | Device: Subcutaneously implanted event recorder (REVEAL LINQ)1st interventional arm, subcutaneously implanted event recorder (REVEAL LINQ) |
| Arm 3 | Other | Device: 28-day non-invasive continuous ECG monitoring (patch)2nd interventional arm, 28-day continuous ECG monitoring |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Written informed consent by patient.
- Age ≥ 50 years.
- TIA diagnosed by a stroke physician defined as rapidly developing clinical signs of focal or global disturbances of cerebral function, lasting less than 24 hours with no apparent non-vascular cause
- 12-channel ECG available before enrolment
- Brain imaging available before enrolment (CCT or cranial MRI)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Subcutaneously implanted event recorder (REVEAL LINQ)Patients receive a subcutaneously implantable cardiac device (REVEAL LINQ). | Device | Arm 2 |
| 28-day non-invasive continuous ECG monitoring (patch)Patients receive a non-invasive continuous ECG monitoring (patch) | Device | Arm 3 |
Primary outcome
Rate of newly detected AF at 6 month after study enrolment in patients with recent TIA
Time frame: 6 month
Self reported or by other means detected newly AF
2 secondary outcomes
Prevalence of AF in TIA patients as determined by prolongend ECG Monitoring techniques
Time frame: 24 month
Rate of newly detected AF at 12 and 24 month after study enrolment in patients with recent TIA
Time frame: 12 and 24 month
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 9 Feb 2026.
- Individual participant dataSharing planned: No
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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Atrial Fibrillation (AF)
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.
Roland Veltkamp, MD principal investigator
Initiator of study, leader PI
27 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcutaneously implanted event recorder (REVEAL LINQ) and 28-day non-invasive continuous ECG monitoring (patch) in people with Atrial Fibrillation and Transient Ischemic Attack, run by Alfried Krupp Krankenhaus at 27 sites in 2 countries.
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 16 inclusion and 0 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 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Germany, Spain. 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?
Rate of newly detected AF at 6 month after study enrolment in patients with recent TIA (time frame: 6 month). 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 9 Feb 2026.