UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058063 |
|---|---|
| Receipt number | R000066206 |
| Scientific Title | Evaluation of the efficacy and safety of stimulated conduction system pacing in adult patients with congenital heart disease. |
| Date of disclosure of the study information | 2025/06/03 |
| Last modified on | 2025/06/03 11:40:24 |
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Basic information
Public title
Evaluation of the efficacy and safety of stimulated conduction system pacing in adult patients with congenital heart disease.
Acronym
Conduction system pacing in adult congenital heart disease
Scientific Title
Evaluation of the efficacy and safety of stimulated conduction system pacing in adult patients with congenital heart disease.
Scientific Title:Acronym
Conduction system pacing in adult congenital heart disease
Region
| Japan |
Condition
Condition
Adult congenital heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the usefulness of conduction system pacing for cardiac function in patients with complex adult congenital heart disease with bradycardia, using lead placement into the conduction system in conjunction with 3D mapping at the time of pacemaker implantation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of the amount of change in ventricular ejection fraction before and after implantation in conduction system pacing and conventional apical pacing.
Key secondary outcomes
Acute success of conduction system pacing
Frequency of lead reinsertion
Change in ventricular ejection fraction before and after conduction system pacing
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) Patients aged 18 years and over with congenital heart disease who are attending or being admitted to the Department of Cardiology, Kyushu University Hospital.
(2) Patients who are judged to be suitable for a pacemaker due to bradycardia and who will undergo transvenous lead implantation.
(3) Patients who fully understand the study and give written consent.
Key exclusion criteria
(1) Patients with active infections.
(2) Patients with metal allergies.
(3) Patients who are pregnant or may become pregnant.
(4) Other patients deemed ineligible for participation in the study by the principal investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tomomi |
| Middle name | |
| Last name | Nagayama |
Organization
Kyushu University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan
TEL
0926425360
nagayama.tomomi.325@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Nagayama |
Organization
Kyushu University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan
TEL
0926425360
Homepage URL
nagayama.tomomi.325@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
MEDTRONIC JAPAN CO., LTD.
IRB Contact (For public release)
Organization
Ethical Review Committee for Observational Research at the Medical District Department of Kyushu University
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan
Tel
092-642-5082
ijkseimei@jimu.kyushu-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
| 2025 | Year | 06 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The procedure flow at the time of pacemaker implantation should be performed as in normal practice and data collected at that time.
At the time of the pacemaker check performed as an outpatient 1 week, 1 month and 1 year after implantation, lead sensitivity, threshold and wave height fluctuations and ventricular pacing rate should be checked.
Perform echocardiography or cardiac MRI one year after implantation to assess changes in ventricular ejection fraction after pacemaker implantation.
Management information
Registered date
| 2025 | Year | 06 | Month | 03 | Day |
Last modified on
| 2025 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066206
