UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052439 |
|---|---|
| Receipt number | R000059852 |
| Scientific Title | Catheter Ablation of Atrial Fibrillation Improves Outcomes in Heart Failure with Systolic Dysfunction: A Meta-Analysis of Updated Randomized Controlled Trials |
| Date of disclosure of the study information | 2023/10/07 |
| Last modified on | 2023/10/07 17:10:23 |
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Basic information
Public title
Catheter Ablation of Atrial Fibrillation Improves Outcomes in Heart Failure with Systolic Dysfunction: A Meta-Analysis of Updated Randomized Controlled Trials
Acronym
Catheter Ablation of Atrial Fibrillation Improves Outcomes in Heart Failure with Systolic Dysfunction: A Meta-Analysis of Updated Randomized Controlled Trials
Scientific Title
Catheter Ablation of Atrial Fibrillation Improves Outcomes in Heart Failure with Systolic Dysfunction: A Meta-Analysis of Updated Randomized Controlled Trials
Scientific Title:Acronym
Catheter Ablation of Atrial Fibrillation Improves Outcomes in Heart Failure with Systolic Dysfunction: A Meta-Analysis of Updated Randomized Controlled Trials
Region
| Japan |
Condition
Condition
Heart failure complicated by atrial fibrillation
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Recent findings from two important randomized clinical trials present data that question the efficacy of atrial fibrillation ablation (RFCA) in patients with advanced heart failure (HF). We therefore present an updated meta-analysis to better understand the prognostic benefits of RFCA.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome of this meta-analysis is the integrated risk ratio of major cardiac events in the ablation and non-ablation groups. Cardiac events were defined as all-cause mortality and hospitalization for worsening heart failure
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Using methods proposed by the Cochrane Collaboration and meeting the reporting criteria of the 202010 Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) guidelines, we searched databases using PubMed, Web of Science Core Collection, and Cochrane advanced search. The following keywords were used: heart failure, heart failure with reduced LVEF, atrial fibrillation ablation, pulmonary vein isolation, improved outcome, randomized clinical trial
Key exclusion criteria
Exclusion criteria were non-RCTs, case reports, animal studies, and non-English language articles.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Kato |
Organization
Yokohama City University Hospital
Division name
Department of Diagnostic Radiology
Zip code
236-0004
Address
3-9, Fukuura, Kanazawaku, Yokohama
TEL
0457872800
shingo.m12226@gmail.com
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | kato |
Organization
Yokohama City University Hospital
Division name
Department of Diagnostic Radiology
Zip code
236-0004
Address
3-9, Fukuura, Kanazawaku, Yokohama
TEL
0457872800
Homepage URL
shingo.m12226@gmail.com
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Shingo Kato
Funding Source
Organization
self funding
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
IRB of Yokohama City University
Address
3-9, Fukuura, Kanazawaku, Yokohama
Tel
0457872800
shingo.m12226@gmail.com
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
| 2023 | Year | 10 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is meta-analysis
Management information
Registered date
| 2023 | Year | 10 | Month | 07 | Day |
Last modified on
| 2023 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059852
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
