NEO-NORMAL-AF Study

JRCT ID: jRCTs052210060

Registered date:06/08/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Heart Failure
• Date of first enrollment: 17/02/2022
• Target sample size: 30
• Study type: Interventional
• Intervention(s): ILR implantation

Outcome(s)

Primary Outcome

The presence / absence# of new onset of atrial fibrillation(recurrence of atrial fibrillation in the case of paroxysmal atrial fibrillation)detected at 12 months after ILR implantation#
*Definition of atrial fibrillation detected with ILR:6 minutes and more persistent atrial fibrillation

Secondary Outcome

1 30 seconds and more persistent supraventricular tachycardia(definition:heart rate over (220-age) beats/minute)*1
2 30 seconds and more persistent ventricular tachycardia(definition : heart rate over 150 beats/minute)*1
3 3 seconds and more R wave to R wave interval
4 bradycardia of 40 beats/minute and lesss heart rate
5 atrial fibrillation burden( atrial fibrillation duration/total observation time ) and number of occurrences during 1 year ILR monitoring in case of paroxysmal atrial fibrillation
6 all death*2, cardiovascular death*3, rehospitalization for heart failure , acute coronary syndrome, Stroke(ischemic or hemorrhagic stroke are no objects)
7 arrhythmia which has class 1 or 2 a indication(definition by 2018 Japanese Circulation Society/Japanese Heart Rhythm Society Guideline on Non-Pharmacotherapy of Cardiac Arrhythmias) for non-drug therapy such as cardiac implantable electrical devices and catheter ablation
8 Detection of atrial fibrillation by electrocardiogram (12-lead electrocardiogram / 3 minutes recording / 7 days Holter electrocardiogram*4)
9 Detection of arrhythmia (Supraventricular tachycardia, ventricular tachycardia, pause, bradycardia) by electrocardiogram (12-lead electrocardiogram / 3 minutes recording / 7 days Holter electrocardiogram*4)

*1 Supraventricular tachycardia or Ventricular tachycardia directly confirmed by electrocardiographic waveform
*2 Death from all causes
*3 Sudden cardiac death, myocardial infarction, congestive heart failure, arrhythmia, death from stroke (ischemic or hemorrhagic are no object)
*4 Use two evaluation points for all recorded hours and up to 24hours from the start of measurement.

#For 1 to 4,8,9 measure the presence or absence, number of onset and the total detection time of arrhythmia. The total detection time in ILR is calculated based on total each event using the Carelink system.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1 Hospitalized patients due to acute heart failure or acute exacerbation of chronic heart failure
2 LVEF 40% or more measured by echocardiography recorded within 2 weeks before getting written consent
3 Ages 20 and over

Exclude criteria

1 Patients with persistent atrial fibrillation or bradyarrhythmia ,which has indication for pacemaker implantation, detected by 12 leads electrocardiogram during hospitalization
2 Patients with tachyarrhythmia ,which has indication for cardiac implantable electronic device or catheter ablation, detected during hospitalization
3 Patients with cardiac implantable electronic device
4 Expected prognosis less than 1 year
5 Inappropriate patients judged by attending doctor

Related Information

• Primary Sponsor: Nishida Taku
• Secondary Sponsor: Saito Yoshihiko
• Source(s) of Monetary Support: MEDTRONIC JAPAN CO., LTD.