An interventional study of 7-day Holter ECG and Implantable cardiac monitor in Ischemic Stroke and Atrial Fibrillation, sponsored by University of Leipzig. Active, not recruiting at 52 sites in Germany. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by University of Leipzig · Not applicable, Interventional, and Prevention
Patients who have suffered a stroke are having an increased risk of having recurrent stroke in the future. This risk of stroke is increased by atrial fibrillation, which often "comes and goes" (called paroxysmal) and hence escapes routine diagnostics. The hypothesis of Find-AF 2 is that enhanced (evaluation in a ECG core lab), prolonged (at least 7 days of rhythm monitoring annually) and intensified (continuous rhythm monitoring in high risk patients) not only finds atrial fibrillation more often, but that changes in therapeutic management (e. g. start of anticoagulation after detection of atrial fibrillation) results in a decrease of cardioembolism (which can be either recurrent stroke or systemic embolism).
To prove this hypothesis, patients will be randomised into two groups: the first group will receive the currently available standard care for patients with stroke. In the second group, cardiac rhythm monitoring adapted to the risk of the occurrence of atrial fibrillation is performed - either with a 7-day long-term ECG (at baseline, after 3 and 12 months and every 12 months thereafter) or with continuous monitoring using an implantable cardiac monitor. If atrial fibrillation is detected, this information will be given to the treating study physician. Any therapeutic decision is at the discretion of the treating physician, but should follow current guidelines.
The Find AF 2 study will investigate whether intensified rhythm monitoring in patients with recent ischemic stroke leads to a decrease in recurrent thromboembolism (defined as recurrent ischemic stroke or systemic embolism). This will be achieved by identifying patients with paroxysmal atrial fibrillation and subsequently switching secondary prevention therapy from antiplatelet therapy to oral anticoagulation. The intensity of heart rhythm monitoring will be risk-adjusted: Patients with an estimated low risk of atrial fibrillation receive a 7-day Holter ECG, which is repeated after 3 and 12 months and annually thereafter. Patients with a high risk of atrial fibrillation (defined by increased supraventricular ectopic activity) receive continuous ECG monitoring using an implanted loop recorder. The control arm is treated according to local standards, which includes cardiac rhythm monitoring for at least 24 hours according to current guidelines. Prior to randomization, a 24-hour Holter ECG is performed in both study arms, ensuring minimal ECG monitoring for patients in the control arm and allowing risk stratification in the intervention arm. Additional ECG monitoring using stroke telemetry and/or additional Holter ECGs is possible according to local standards, provided it does not exceed 7 days. Patients in both study arms will be followed up for at least 24 months.
It should be noted that this study only provides diagnostic information, the therapeutic decision is left to the treating physician.
2,595 studies on the registry are indexed under Ischemic Stroke; 932 are open to participants now.
This study's enrollment of 5,227 is above the median of 120 across 1,754 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →University of Leipzig is the lead sponsor of 147 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intervention Group with high Risk for AF: Continuous Rhythm Monitoring using an implantable cardiac Monitor Intervention group with low risk for AF: 7-day Holter ECG at baseline, after 3 and 12 months and then annually until the end of the study or the first occurrence of atrial Fibrillation
Other: 7-day Holter ECG · Other: Implantable cardiac monitor
Standard of care rhythm monitoring
Other: Standard of care
7-day Holter ECG at baseline and after 3 and 12 months and then annually until the end of the study or the first (in patients with low risk of atrial fibrillation)
Continuous rhythm monitoring using an implantable cardiac monitor
Usual care according to current guidelines (in patients with low and high risk of atrial fibrillation)
Primary efficacy endpoint: Time until recurrent ischemic stroke or systemic embolism
The trial will be event driven. The minimum follow-up in each patient is 24 months, but may be followed for up to 60 months.
Time frame: from the date of randomization until the date of first documented ischemic stroke or date of first systemic embolism, whichever comes first, assessed up to 60 months
Primary safety endpoint: Time until the first haemorrhagic stroke
Time until the first haemorrhagic stroke
Time frame: from the date of randomization until the date of first documented haemorrhagic stroke, assessed up to 60 months
Time until the combination of stroke, myocardial infarction and cardiovascular death
Time until the combination of stroke, myocardial infarction and cardiovascular death
Time frame: from the date of randomization until the date of first documented stroke, the date of myocardial infarction and the date of cardiovascular death, whichever comes first, assessed up to 60 months
Time until any stroke
Time until any stroke
Time frame: from the date of randomization until the date of first documented any stroke, assessed up to 60 months
Time until new onset of AF
Time until new onset of Atrial Fibrillation
Time frame: from the date of randomization until the date of first documented AF, assessed up to 60 months
Time until all cause mortality
Time until all cause mortality
Time frame: from the date of randomization until the date of all cause mortality assessed up to 60 months
Time until myocardial infarction
Time until myocardial infarction
Time frame: from the date of randomization until the date of all myocardial infarction, assessed up to 60 months
Changes in quality of life (QoL), measured by the stroke impact scale (SIS-16)
Changes in quality of life (QoL), measured by the stroke impact scale (SIS-16). The SIS-16 ranges from 16 to 80, with higher scores showing better Quality of life.
Time frame: Mean change from baseline until study end assessed up to 60 months in both study arms
Changes in the EQ-5D five dimensional Quality of Life (QoL)
Changes in the EQ-5D five dimensional Quality of Life (QoL)
Time frame: Mean change from baseline until study end assessed up to 60 months in both study arms
Changes in the overall QoL visual analog scale
Changes in the overall QoL visual analog scale
Time frame: Mean change from baseline until study end assessed up to 60 months in both study arms, ranging from 0 to 100, with higher values indicating better quality of life
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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University of Leipzig