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

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 -

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs042250030
Enrollment
140
Registered
2025-05-22
Start date
2025-06-17
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atrioventricular block

Interventions

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.

Sponsors

Naruse Yoshihisa
Lead Sponsor
BIOTRONIK Japan, Inc
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

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

Secondary

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

Contacts

Public ContactYoshihisa Naruse

Hamamatsu University School of Medicine

naruse@hama-med.ac.jp+81-53-435-2356

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026