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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043611
Receipt No. 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 2021/03/14

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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 initial 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
4. Patients with a previous open heart surgery
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, Higashi-ward, Hamamatsu, Japan
TEL +81-53-435-2267
Email 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, Higashi-ward, Hamamatsu, Japan
TEL +81-53-435-2267
Homepage URL
Email makosano@hama-med.ac.jp

Sponsor
Institute Hamamatsu university school of medicine
Institute
Department

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, Higashi-ward, Hamamatsu, Japan
Tel +81-53-435-2680
Email 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
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 Preinitiation
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
2021 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049793

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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