UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051672 |
|---|---|
| Receipt number | R000058964 |
| Scientific Title | A Multicenter Prospective Study Evaluating Pacemaker Implantation and Catheter Ablation for Comprehensive Outcomes in Tachycardia-Bradycardia Syndrome |
| Date of disclosure of the study information | 2023/09/20 |
| Last modified on | 2025/01/21 18:45:01 |
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Basic information
Public title
A Multicenter Prospective Study Evaluating Pacemaker Implantation and Catheter Ablation for Comprehensive Outcomes in Tachycardia-Bradycardia Syndrome
Acronym
EPIC-TBS
Scientific Title
A Multicenter Prospective Study Evaluating Pacemaker Implantation and Catheter Ablation for Comprehensive Outcomes in Tachycardia-Bradycardia Syndrome
Scientific Title:Acronym
EPIC-TBS
Region
| Japan |
Condition
Condition
Tachycardia-bradycardia syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research is to compare the selected invasive treatments for pacemaker treatment and catheter ablation treatment and their background factors, as well as clarifying clinical outcomes and related predictive factors in patients with tachycardia-bradycardia syndrome.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in quality of life assessment scale from before treatment to 6 months and 12 months after the initial pacemaker therapy or catheter ablation therapy, diagnosed as tachy-brady syndrome.
This study will utilize either the AFEQT, the Short Form-12, or the EQ-5D-5L as the assessment tools for quality of life.
Key secondary outcomes
Complications during pacemaker or ablation therapy.
Adverse events within 24 months after treatment, such as:
Mortality, stroke, systemic embolism, major bleeding events, hospitalization for heart failure, syncope, pacemaker lead infection or extraction, or catheter ablation after the initial procedures.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following conditions will be included in this study:
1. Either of the following two criteria will be observed at the cessation of atrial ectopic tachycardia, atrial fibrillation, atrial flutter, or atrial tachycardia (supraventricular tachycardia) :
1-1. The sinus pause time after the cessation of supraventricular tachycardia is more than 5 seconds.
1-2. The sinus pause time after the cessation of supraventricular tachycardia is more than 3 seconds, and it causes by the sinus pause or it is plausible that the pauses cause symptoms related to tachycardia-bradycardia syndrome within the last three.
2. They are scheduled for either catheter ablation or pacemaker implantation therapy within the next three months.
3. Written consent for participation in the study can be obtained from the individual.
Key exclusion criteria
Patients who meet any of the following criteria from 1 to 7 will be excluded from this study:
1. Patients who have previously received any of the following treatments:
Catheter ablation for atrial fibrillation, maze surgery, permanent pacemaker implantation, mechanical heart valve replacement surgery. ]
2. Patients with a left ventricular ejection fraction less than 40%
3. Patients exhibiting complete atrioventricular block, advanced atrioventricular block, or complete left bundle branch block
4. Patients with a disease prognosis estimated to be less than one year
5. Patients for whom catheter ablation or permanent pacemaker procedures are considered difficult due to anatomical reasons from previous medical history
6. Cases where responses to the Quality of Life (QoL) questionnaire are difficult due to dementia or similar conditions
7. Other patients whom the research leader determines to be inappropriate as study subjects.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Shunsuke |
| Middle name | |
| Last name | Kuroda |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-8421
Address
2 Chome-1-1 Hongo, Bunkyo City, Tokyo
TEL
03-3813-3111
s.kuroda.qm@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Kuroda |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-8421
Address
2 Chome-1-1 Hongo, Bunkyo City, Tokyo
TEL
03-3813-3111
Homepage URL
s.kuroda.qm@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine, Department of Cardiovascular Biology and Medicine, Shunsuke Kuroda
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee Faculty of Medicine, Juntendo University
Address
3chome 1-3, Hongo, Bunkyo-ku, Tokyo
Tel
03-5802-1584
hongo-rinri@juntendo.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
| 2023 | Year | 09 | Month | 20 | 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
| 2023 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2027 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
This study is a multicenter prospective observational study that will be conducted in Japan. Patients who present to the study institution between the date of study approval and September 30, 2025, with a diagnosis of tachycardia-bradycardia syndrome and scheduled for pacemaker or catheter ablation therapy will be enrolled. The registry will collect information of patients' backgrounds, laboratory findings, and quality of life (QoL) which will be assessed with QoL scoring system. Outcomes of the study will be the changes in the QoL assessment score at 6 and 12 months from baseline, and adverse events such as death, embolism, bleeding, hospitalization, and syncope will also be followed within 2 months after the interventions.
Management information
Registered date
| 2023 | Year | 07 | Month | 21 | Day |
Last modified on
| 2025 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058964
