UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060737 |
|---|---|
| Receipt number | R000069486 |
| Scientific Title | A Multicenter Observational Study of Pacemaker Implantation in Patients With Advanced Atrioventricular Block and Preserved or Moderately Reduced Left Ventricular Ejection Fraction (>35%) |
| Date of disclosure of the study information | 2026/02/24 |
| Last modified on | 2026/02/24 07:10:15 |
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Basic information
Public title
A Multicenter Observational Study of Pacemaker Implantation in Patients With Advanced Atrioventricular Block and Preserved or Moderately Reduced Left Ventricular Ejection Fraction (>35%)
Acronym
REAL-AV Study
Scientific Title
A Multicenter Observational Study of Pacemaker Implantation in Patients With Advanced Atrioventricular Block and Preserved or Moderately Reduced Left Ventricular Ejection Fraction (>35%)
Scientific Title:Acronym
REAL-AV Study
Region
| Japan |
Condition
Condition
Advanced atrioventricular block (including complete atrioventricular block)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the real-world implantation rates of various cardiac pacing devices in patients with advanced atrioventricular block and left ventricular ejection fraction greater than 35% who are expected to require ventricular pacing, to evaluate the reasons for device selection and differences in clinical outcomes, and to assess the impact of pacing site and pacing mode on cardiac function and infection risk.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Implantation rate of each pacing device type
Key secondary outcomes
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
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key 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
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Okumura |
Organization
Nihon University School of Medicine
Division name
Division of Cardiology, Department of Medicine
Zip code
173-8610
Address
30-1 Ohyaguchi, Kamicho, Itabashi-ku, Tokyo
TEL
03-3972-8111
okumura.yasuo@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukitoshi |
| Middle name | |
| Last name | Ikeya |
Organization
Nihon University School of Medicine
Division name
Division of Cardiology, Department of Medicine
Zip code
173-8610
Address
30-1 Ohyaguchi, Kamicho, Itabashi-ku, Tokyo
TEL
03-3972-8111
Homepage URL
ikeya.yukitoshi@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Funding Source
Organization
Medtronic Co
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Dokkyo Medical University Saitama Medical Center (Co-Principal Investigator Shiro Nakahara)
Nihon University Hospital
Kawaguchi Municipal Medical Center
Tokyo Rinkai Hospital
Kasukabe Municipal Medical Center
TMG Asaka Medical Center
JCHO Yokohama Central Hospital
Dokkyo Medical University Hospital
Kasukabe Central General Hospital
San-aikai General Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Itabashi Hospital, Clinical Research Judging Committee
Address
30-1 Ohyaguchi, Kamicho, Itabashi-ku, Tokyo
Tel
03-3972-8111
med.itabashi.chiken@nihon-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Suspended
Date of protocol fixation
| 2025 | Year | 11 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2026 | Year | 02 | Month | 24 | Day |
Last modified on
| 2026 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069486
