A Multicenter Observational Study of Pacemaker Implantation in Patients With Advanced Atrioventricular Block and Preserved or Moderately Reduced Left Ventricular Ejection Fraction (>35%)

A Multicenter Observational Study of Pacemaker Implantation in Patients With Advanced Atrioventricular Block and Preserved or Moderately Reduced Left Ventricular Ejection Fraction (>35%) - REAL-AV Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000060737

Enrollment

400

Registered

2026-02-24

Start date

2026-03-02

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

Advanced atrioventricular block (including complete atrioventricular block)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Age 18 years or older at the time of obtaining informed consent (2) Advanced or third-degree atrioventricular block with an expected high burden of ventricular pacing (>20%), left ventricular ejection fraction greater than 35%, and first implantation of a cardiac implantable device

Exclusion criteria

Exclusion criteria: (1) Patients who are not expected to survive for at least 12 months (2) Patients with drug-refractory severe congestive heart failure classified as NYHA functional class IV who are not candidates for heart transplantation, CRT, or LVAD (3) Patients who expressed refusal to participate in this study (4) Patients deemed inappropriate as study subjects by the principal investigator

Design outcomes

Primary

Measure	Time frame
Implantation rate of each pacing device type	—

Secondary

Measure	Time frame
Key secondary outcomes in each group (LVEF 36-50% and LVEF >50%): (1) NT-proBNP and BNP (2) Echocardiographic parameters (LVEF and LVESV [left ventricular end-systolic volume]) (3) All-cause mortality (4) Cardiovascular events (stroke/transient ischemic attack, systemic embolism, ischemic heart disease, cardiovascular death, hospitalization for heart failure, and other cardiovascular events requiring hospitalization) (5) Myocardial infarction and unstable angina (6) Hospitalization for heart failure and other cardiovascular events requiring hospitalization (7) Major bleeding (according to ISTH criteria) (8) Clinically relevant bleeding (9) Major bleeding or clinically relevant bleeding (10) Occurrence of VT (ventricular tachycardia) / VF (ventricular fibrillation) and sudden death (11) Cardiovascular death (12) Other causes of death (13) Device-related complications	—

Measure

Time frame

Key secondary outcomes in each group (LVEF 36-50% and LVEF >50%): (1) NT-proBNP and BNP (2) Echocardiographic parameters (LVEF and LVESV [left ventricular end-systolic volume]) (3) All-cause mortality (4) Cardiovascular events (stroke/transient ischemic attack, systemic embolism, ischemic heart disease, cardiovascular death, hospitalization for heart failure, and other cardiovascular events requiring hospitalization) (5) Myocardial infarction and unstable angina (6) Hospitalization for heart failure and other cardiovascular events requiring hospitalization (7) Major bleeding (according to ISTH criteria) (8) Clinically relevant bleeding (9) Major bleeding or clinically relevant bleeding (10) Occurrence of VT (ventricular tachycardia) / VF (ventricular fibrillation) and sudden death (11) Cardiovascular death (12) Other causes of death (13) Device-related complications

—

Countries

Japan

Contacts

Public ContactYukitoshi Ikeya

Nihon University School of Medicine Division of Cardiology, Department of Medicine

ikeya.yukitoshi@nihon-u.ac.jp03-3972-8111

Outcome results