Investigation of the usefulness of continuous arrhythmia monitoring using an implantable loop recorder in heart failure patients with reduced left ventricular ejection fraction.

JRCT ID: jRCTs032240593

Registered date:06/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: HFrEF patients without AF
• Date of first enrollment: 06/01/2025
• Target sample size: 35
• Study type: Interventional

Intervention(s)

After obtaining written consent, the principal (sub)investigator will implant the ILR subcutaneously in the left anterior thoracic region under local anaesthesia.
After implantation, arrhythmic events as defined in this study will be evaluated by remote monitoring (Medtronic CareLink system) every 6 months.
For the primary and secondary endpoints (No.1-3), if an event is detected by remote monitoring, an alert will be sent or forwarded via email to a different evaluating physician, who will be independent of the outpatient physician.
The physician in charge of the evaluation checks the recorded ECG on the server and makes a diagnosis.
If necessary, he or she will report the findings to the outpatient physician.
If the patient is symptomatic, the ILR data will be reviewed as needed.
In addition, as before ILR implantation, outpatient visits will be made every 1 to 3 months.
In this context, the clinical course, including the condition of the study subjects, including the presence or absence of events that fall under the secondary endpoints (No.4-8), will be confirmed.

Outcome(s)

Primary Outcome

Percentage of patients with AF and non-sustained or sustained ventricular tachycardia
AF:lasting more than 6 minutes.
Non-sustained ventricular tachycardia:Tachycardia with a heart rate exceeding 150 beats / minute, 16 or more consecutive beats, and a duration of 30 seconds or less.
Sustained ventricular tachycardia:Tachycardia with a heart rate exceeding 150 beats / minute and lasting more than 30 seconds.

Secondary Outcome

1.Percentage of patients with pauses longer than 4.5 seconds.
2.Percentage of patients with bradycardia of less than 30 beats / min.
3.Percentage of patients with high degree atrioventricular block.
4.Percentage of patients treated with a permanent pacemaker,implantable cardioverter defibrillator,catheter ablation, or antiarrhythmic drug.
5.All-cause mortality
6.Cardiovascular mortality rate
7.Proportion of patients requiring hospitalization for cardiovascular disease or heart failure.
8.Percentage of patients who had a stroke.
<Safety Evaluation Index>
9.Percentage of adverse events associated with ILR implantation
10.Percentage of device malfunction

Key inclusion & exclusion criteria

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

Include criteria

1.Patients with HFrEF (left ventricular ejection fraction <= 40%).
2.Patients with HFrEF who are receiving appropriate medical therapy and are on outpatient treatment or are able to go on outpatient treatment.
3.Patients with a CHADS2 score of 1 or higher.
4.Patients must be at least 20 years of age at the time of consent.
5.Patients who have given written consent to participate in this clinical study.

Exclude criteria

1. Patients with implantable cardiac devices capable of detecting supraventricular arrhythmias (CIED: cardiovascular implantable electronic device. Refers to permanent pacemaker, implantable cardioverter defibrillator, ILR)
2.Patients with a diagnosis of AF at the time of consent.
3.Patients whose prognosis for life is considered to be within 1 year.
4.Patients who are immunocompromised.
5.Patients with active infection.
6.Patients with thin subcutaneous tissue at the implantation site that makes it difficult to safely implant the ILR.
7.Patients who are judged as ineligible for registration by attending doctors.

Related Information

• Primary Sponsor: Miyazaki Shinsuke