UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043611 |
|---|---|
| Receipt number | R000049793 |
| Scientific Title | Assessment of intracardiac electrocardiogram of atrial antitachycardia pacing therapy for atrial tachyarrhythmias |
| Date of disclosure of the study information | 2021/03/14 |
| Last modified on | 2024/06/16 17:33:17 |
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Basic information
Public title
Assessment of intracardiac electrocardiogram of atrial antitachycardia pacing therapy for atrial tachyarrhythmias
Acronym
Intracardiac electrocardiogram of atrial antitachycardia pacing therapy
Scientific Title
Assessment of intracardiac electrocardiogram of atrial antitachycardia pacing therapy for atrial tachyarrhythmias
Scientific Title:Acronym
Intracardiac electrocardiogram of atrial antitachycardia pacing therapy
Region
| Japan |
Condition
Condition
atrial tachyarrhythmias
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment and optimization of intracardiac electrocardiogram of atrial antitachycardia pacing therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pacing capture sites and numbers during atrial antitachycardia pacing therapy
Key secondary outcomes
1. Tachycardia cycle length at the termination of atrial tachyarrhythmia
2. Pacing capture sites and excitation patterns during atrial antitacyardia pacing therapy
3. Pacing numbers needing local capture of right atrium, left atrium or both atria
4. Duration of termination of atrial tachyarrhythmia
5. Sequence numbers of termination of atrial tachyarrhythmia
6. Efficacy of optimization (Success rates of termination and Reduction of sequence numbers)
7. Rhythm change
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
1. Reprogramming of first sequence (A-S1 interval) which achieved termination of tachycardia
2. Assessment of reprogramming in reinduction of atrial arrhythmias
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
1. Ages 20 and over
2. Patients implanted with pacemaker or ICD with atrial antitachycardia pacing therapy more than two months
3. Patients who undergo catheter ablation for atrial tachyarrhythmias (atrial fibrillation or atrial flutter)
4. Patients provided with informed consent
Key exclusion criteria
1. Patients with unstable hemodynamic states
2. Patients who cannot safely undergo the procedure by the study
3. Patients ineligible to the study judged by the investigators
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Sano |
Organization
Hamamatsu university school of medicine
Division name
Division of Cardiology, Internal Medicine 3rd
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ward, Hamamatsu, Japan
TEL
+81-53-435-2267
makosano@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Sano |
Organization
Hamamatsu university school of medicine
Division name
Division of Cardiology, Internal Medicine 3rd
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ward, Hamamatsu, Japan
TEL
+81-53-435-2267
Homepage URL
makosano@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu university school of medicine
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
Hamamatsu university school of medicine
Address
1-20-1 Handayama, Chuo-ward, Hamamatsu, Japan
Tel
+81-53-435-2680
rinri@hama-med.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
| 2021 | Year | 03 | Month | 14 | 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
| Delay expected |
Results Delay Reason
There are few candidates than expected.
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
| 2021 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 14 | Day |
Last modified on
| 2024 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049793
