臨床研究等提出・公開システム

A clinical trial to compare the changes in left ventricular ejection fraction after pacemaker implantation in patients with atrioventricular block between right ventricular septal pacing and left leg area pacing - Mt FUJI II (coMparison of righT ventricular septal pacing and leFt bUndle branch area pacing regarding the changes in left ventricular eJectIon fractIon in patIents with atrioventricular block) trial -

Comparative Study of Left Ventricular Ejection Fraction Change After Pacemaker Implantation in Right Ventricular Septal Pacing and Left Leg Area Pacing

Naruse Yoshihisa

Hamamatsu University School of Medicine

1-20-1,Handayama,Chuo-ku,Hamamatsu,Shizuoka

ynaruse@hama-med.ac.jp

Naruse Yoshihisa

Hamamatsu University School of Medicine

1-20-1,Handayama,Chuo-ku,Hamamatsu,Shizu

+81-53-435-2356

naruse@hama-med.ac.jp

Recruiting

May. 22, 2025

Interventional

randomized controlled trial

single blind

active control

parallel assignment

treatment purpose

1. Patients 18 years of age or older
2. Patients diagnosed with atrioventricular block and expected to undergo ventricular pacing at high frequency
3. Patients scheduled for initial pacemaker implantation according to the latest Japanese Society of Cardiology/JAAPE guidelines
4. Patients with a left ventricular ejection fraction (LVEF) of 50% or higher on echocardiography
5.Patients who are able to make outpatient visits according to the study schedule
6.atients who can be followed up for 2 years after pacemaker implantation
7. Persons who are able to obtain the written consent of the individual or a surrogate to participate in this study

1. patients diagnosed with persistent atrial fibrillation
2. patients with communication status that makes it difficult to respond to the QOL survey
3. patients with chronic renal failure on regular hemodialysis
4. patients with a history of cardiac surgery
5. patients with congenital heart disease
6. patients whom the principal investigator or subinvestigators determine are not appropriate to participate in this study

Both

atrioventricular block

In the right ventricular septal pacing group, the ventricular lead is placed in the right ventricular septum; in the left leg area pacing group, the ventricular lead is placed in the left leg area.
Pacemaker implantation.

Amount of change in left ventricular ejection fraction immediately after implantation and 2 years after implantation

QRS width of pacing
Incidence of PICM
Composite endpoint of PICM, heart failure hospitalization, upgrade to biventricular pacing, and death
Quality of life survey

+81-53-435-2680

May. 02, 2025

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