UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045015 |
|---|---|
| Receipt number | R000051397 |
| Scientific Title | A study of novel unipolar electrogram criteria for patients with tachycardia-induced cardiomyopathy by means of electroanatomical mapping |
| Date of disclosure of the study information | 2021/07/30 |
| Last modified on | 2021/07/30 16:15:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study of novel unipolar electrogram criteria for patients with tachycardia-induced cardiomyopathy by means of electroanatomical mapping
Acronym
A study of novel unipolar electrogram criteria for patients with tachycardia-induced cardiomyopathy by means of electroanatomical mapping
Scientific Title
A study of novel unipolar electrogram criteria for patients with tachycardia-induced cardiomyopathy by means of electroanatomical mapping
Scientific Title:Acronym
A study of novel unipolar electrogram criteria for patients with tachycardia-induced cardiomyopathy by means of electroanatomical mapping
Region
| Japan |
Condition
Condition
Tachycardia-induced cardiomyopathy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate and determine whether unipolar voltage of electro-anatomical mapping in ventricle is useful in identifying reversible cardiomyopathy in newly diagnosed patients with left ventricular systolic dysfunction associated with tachyarrhythmia.
Basic objectives2
Others
Basic objectives -Others
Functional Assessment
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measure ventricular unipolar voltage wave height, area of abnormal potential (<8.27mV) and percentage of total
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Ventricular mapping during catheter ablation for patients with atrial fibrillation and atrial tachycardia with preserved left ventricular contractility.
Interventions/Control_2
Ventricular mapping during catheter ablation for non-ischemic cardiomyopathy with reduced left ventricular contractility and complications of atrial fibrillation and atrial tachycardia.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Study group
Age 18 years or older
Patients with persistent atrial fibrillation or atrial tachycardia (confirmed within 2 weeks of inclusion)
Left ventricular ejection fraction (LVEF) calculated by Modified Simpson method on transthoracic echocardiography is less than 40%.
Patients with unexplained systolic dysfunction not related to coronary artery disease
Patients who have an indication for atrial fibrillation or atrial tachycardia ablation and wish to undergo ablation in the usual course of treatment.
Control group
Age 18 years or older
Persistent atrial fibrillation or atrial tachycardia (confirmed within 2 weeks of inclusion)
Left ventricular ejection fraction (LVEF) of 55% or higher
Patients who have an indication for atrial fibrillation or atrial tachycardia ablation and wish to undergo ablation.
Key exclusion criteria
Cases that cannot agree to participate in the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Akashi |
Organization
St. marianna university
Division name
Cardiology
Zip code
2168511
Address
2-16-1 Sugo, Miyamae Ward, Kawasaki City, Kanagawa Prefecture
TEL
044-977-8111
junkanki@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Togashi |
Organization
St. marianna university
Division name
cardiology
Zip code
2168511
Address
2-16-1 Sugo, Miyamae Ward, Kawasaki City, Kanagawa Prefecture
TEL
044-977-8111
Homepage URL
daisuke.togashi@marianna-u.ac.jp
Sponsor or person
Institute
St.marianna university
Institute
Department
Personal name
Funding Source
Organization
St.marianna university
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
St.marianna university
Address
2-16-1 Sugo, Miyamae Ward, Kawasaki City, Kanagawa Prefecture
Tel
044-977-8111
k-sienbu.mail@marianna-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
| 2021 | Year | 07 | Month | 30 | 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 | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | 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 | 07 | Month | 30 | Day |
Last modified on
| 2021 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051397
