Long-term monitoring of post-heart transplant patients with an implantable electrocardiograph

JRCT ID: jRCTs072240026

Registered date:02/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: After heart transplantation
• Date of first enrollment: 23/08/2024
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Subcutaneous implantation of implantable electrocardiographs

Outcome(s)

• Primary Outcome: Incidence of fatal arrhythmias (ventricular fibrillation/ventricular tachycardia/atrioventricular block/sick sinus syndrome)

Secondary Outcome

Incidence of all-cause mortality or sudden death or non-fatal arrhythmias
Time from post-heart transplant to the onset of fatal arrhythmias/all-cause death/sudden death

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients who have given their free and written consent
(2) Patients who are at least 18 years of age at the time consent is given
(3) Patients following heart transplantation

Exclude criteria

(1) Patients with implanted cardiac implantable devices (pacemakers (including CRTs), implantable defibrillators (including CRTDs), loop recorders)
(2) Patients with active infections
(3) Patients with metal allergies
(4) Patients with psychiatric disorders or psychiatric symptoms that interfere with daily life and make participation in the study difficult
(5) Other patients deemed by the investigator to be ineligible for participation in the study.

Related Information

• Primary Sponsor: Kinugawa Shintaro
• Secondary Sponsor: Shiose Akira
• Source(s) of Monetary Support: MEDTRONIC JAPAN CO., LTD.