UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046170 |
|---|---|
| Receipt number | R000052701 |
| Scientific Title | Prediction of the recovery in the left ventricular ejection fraction after catheter ablation of atrial fibrillation using pre-procedural troponin I |
| Date of disclosure of the study information | 2021/11/25 |
| Last modified on | 2021/11/24 23:29:58 |
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Basic information
Public title
Prediction of the recovery in the left ventricular ejection fraction after catheter ablation of atrial fibrillation using pre-procedural troponin I
Acronym
Troponin I and AF ablation study
Scientific Title
Prediction of the recovery in the left ventricular ejection fraction after catheter ablation of atrial fibrillation using pre-procedural troponin I
Scientific Title:Acronym
Troponin I and AF ablation study
Region
| Japan |
Condition
Condition
atrial fibrillation with reduced left ventricular ejection fraction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective was to explore that usefulness of troponin I as a predictor of LVEF recovery, biomarker, and left arterial remodeling after catheter ablation in AF patients with reduced LVEF.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
a recovery of left ventricular ejection fraction after atrial fibrillation ablation
Key secondary outcomes
all cause death, hospitalization due to heart failure
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
atrial fibrillation patients with a reduced LVEF (<50%) before the catheter ablation.
Key exclusion criteria
the patients with severe LV dysfunction (LVEF<25%), those without follow-up data at > 3 months after the procedure, those with implanted cardiac resynchronization therapy devices and those with renal failure on hemodialysis was excluded.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Tada |
Organization
University of Fukui
Division name
Department of Cardiovascular Medicine, Faculty of Medical Sciences
Zip code
910-1193
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan
TEL
0776-61-3111
daisetsu@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Daisetsu |
| Middle name | |
| Last name | Aoyama |
Organization
University of Fukui
Division name
Department of Cardiovascular Medicine, Faculty of Medical Sciences
Zip code
910-1193
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan
TEL
0776-61-3111
Homepage URL
daisetsu@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Funding Source
Organization
University of Fukui
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Fukui
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan
Tel
0776-61-3111
daisetsu@u-fukui.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 | 11 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 11 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Troponin I levels were examined prior to and at 1 month after AF ablation and echocardiographic parameters and other laboratory data were obtained prior to, and at more than 3 months after the procedure.
Management information
Registered date
| 2021 | Year | 11 | Month | 24 | Day |
Last modified on
| 2021 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052701
