UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054880 |
|---|---|
| Receipt number | R000062484 |
| Scientific Title | The safety and usefulness of atrial septal pacing with delivery catheter and intraoperative electrocardiogram |
| Date of disclosure of the study information | 2024/07/04 |
| Last modified on | 2024/09/20 15:12:10 |
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Basic information
Public title
The safety and usefulness of atrial septal pacing with delivery catheter and intraoperative electrocardiogram
Acronym
The safety and usefulness of atrial septal pacing
Scientific Title
The safety and usefulness of atrial septal pacing with delivery catheter and intraoperative electrocardiogram
Scientific Title:Acronym
The safety and usefulness of atrial septal pacing
Region
| Japan |
Condition
Condition
Sick sinus syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Conventional pacemakers have been implanted with the right atrial lead in the right atrial appendage and the right ventricular lead in the apex. However, with the use of delivery catheters and intraoperative 12-lead ECGs, right ventricular leads can now be safely placed from the apex into the right ventricular septum and stimulating conduction system, and have been shown to be effective. Previous studies have shown that right atrial leads placed in the right atrial septum can shorten interatrial conduction time, which has been expected to reduce atrial fibrillation, but the results have been controversial.1) The reason for this result may be due to the lack of use of delivery catheters and intraoperative ECGs. We have shown in a retrospective study that pacemaker implantation using Medtronic's delivery catheter to place an atrial lead in the atrial septum in patients with sick sinus syndrome is safe and potentially effective in reducing atrial fibrillation.2) However, prospective randomized studies are needed to further build high-quality evidence.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety: threshold, wave height, resistance, and complication rates including lead dislodgement
Effectiveness: P-wave width (interatrial conduction time) at induction II, atrial fibrillation duration, AT/AF rate
Key secondary outcomes
Safety: Tip position of atrial lead (confirmed by simple CT)
Effectiveness: Echocardiographic data (left atrial diameter, left atrial volume, left ventricular ejection fraction), blood sample data (NT-proBNP)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Right atrial appendage pacing
Interventions/Control_2
Atrial septarl pacing
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with symptomatic sick sinus syndrome and indication for pacemaker implantation
Key exclusion criteria
Under 20 years of age, history of long-term persistent atrial fibrillation, history of catheter ablation, history of cardiac surgery
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Hironobu |
| Middle name | |
| Last name | Sumiyoshi |
Organization
Kurashiki Central Hospital
Division name
Cardiology
Zip code
710-0052
Address
1-1-1 Miwa, Kurashiki, Okayama
TEL
086-422-0210
hs17457@kchnet.or.jp
Public contact
Name of contact person
| 1st name | Hironobu |
| Middle name | |
| Last name | Sumiyoshi |
Organization
Kurashiki Central Hospital
Division name
Cardiology
Zip code
710-0052
Address
1-1-1 Miwa, Kurashiki, Okayama
TEL
086-422-0210
Homepage URL
hs17457@kchnet.or.jp
Sponsor or person
Institute
Kurashiki Central Hospital
Institute
Department
Personal name
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurashiki Central Hospital
Address
1-1-1 Miwa, Kurashiki, Okayama
Tel
086-422-0210
hs17457@kchnet.or.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
| 2024 | Year | 07 | Month | 04 | 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
Completed
Date of protocol fixation
| 2024 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 04 | Day |
Last modified on
| 2024 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062484
