NCT05431972Completed
Cardea SOLOTM for Paroxysmal Atrial Fibrillation Diagnosis in ESUS Patients With Left Atrial Enlargement
Efficacy and Safety of Cardea SOLOTM for Paroxysmal Atrial Fibrillation Diagnosis in ESUS Patients With Left Atrial Enlargement: Prospective, Multi-center, Open-label, Randomized, Controlled, Investigator-Initiated Trial
Source: ClinicalTrials.gov · Last updated 15 Dec 2025
Brief summary (registry, in English)
The aim of the study is to evaluate the efficacy and safety of the Cardea SOLO Compared to 12 lead EKG for Paroxysmal Atrial Fibrillation Diagnosis in ESUS patients with Left Atrial Enlargement.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 257 (actual)
- First submitted
- 17 Jun 2022
- Start date
- 1 Nov 2022
- Primary completion date
- 13 Sept 2024
- Lead sponsor
- Asan Medical Center
- Diseases
- Stroke, Atrial fibrillation
- NCT number
- NCT05431972
What you commit to
- Study type: Interventional
- Participants enrolled: 257
- From 1 Nov 2022 to the primary completion date, 13 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Radiation therapy or MRI scan
Other illness
- Active cancer
- Heart embolism, stroke of major heart embolism, stroke high-risk disease
- Sick sinus syndrome
- Rheumatic left atrioventricular valve or aortic valve disease
- Artificial heart valve
- Congestive heart failure (EF\<30%)
- Restriction for echocardiography (obesity, lung disease etc)
- Patch apply difficulty(skin allergy, ulticaria, atopic dermatitis, hyperhidrosis)
- Implant cardiac pacemaker
- Life-threatening arrhythmia
Other
- Transient cerebral ischemic attack
- Left atrial thrombus
- Left ventricular thrombus
- Myocardiac infarction in 1 month
- Myocardiac infarction (EF\<28%)
- Dilated cardiomyopathy
- Nonbacterial thrombotic endocarditis
- Endocarditis
- Intracardiac mass
- Atrial fibrillation
- High risk PFO
- Restriction for Cardia SOLO attachment
- The person who investigator judged unsuitable for the trial
Who the study is looking for
- Inclusion NO. 3 or 4 must be satisfied, and No. 2, 5 and 6 must be satisfied.
- 2\. On the Screening date, Stroke onset date is not over 60 days.
- 3\. ESUS Diagnosis : all of a\~e must be satisfied.
- a. Ischemic stroke detected by CT or MRI that is not lacunar
- b. A person without arteriosclerosis which causes at least 50% stenosis of the intracranial/external arteries supplied to the ischemic site
- c. During continuous monitoring or halter monitoring In the stroke intensive care unit, Person without atrial fibrillation and persistent atrial fibrillation
- d. When checked the Transthoracic echocardiography, No major risk cardioembolic source of embolism. (ex. Myocardial infarction within 4 weeks, mitral stenosis, artificial heart valve and so on)
- e. NO other specific cause of stroke identified(et, arteritis, dissection and drug abuse)
- 4\. cardioembolism is classified by TOAST classification.
- 5\. Left ventricle Enlargement(male \>40mm, female \>38mm, LAVI \>35ml/m2
- 6\. Voluntarily sign the consent form
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| BumJoon Kim Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.