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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000046170
Receipt No. 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

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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
Email 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
Email daisetsu@u-fukui.ac.jp

Sponsor
Institute University of Fukui
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052701

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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