UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051524 |
|---|---|
| Receipt number | R000058779 |
| Scientific Title | Randomized controlled trial evaluating the safety and effectiveness of CARTOFINDER guided substrate ablation for non-paroxysmal AF. |
| Date of disclosure of the study information | 2023/07/05 |
| Last modified on | 2024/01/05 16:06:35 |
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Basic information
Public title
A Prospective Randomized Clinical Trial to Validate Atrial Fibrillation Substrate Ablation for Non-Paroxysmal Atrial Fibrillation
Acronym
FINGER AF Trial
Scientific Title
Randomized controlled trial evaluating the safety and effectiveness of CARTOFINDER guided substrate ablation for non-paroxysmal AF.
Scientific Title:Acronym
Randomized controlled FINGER AF trial (FINder Guided sabstratE Radiofrequency catheter ablation for non-pAF)
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It was reported that approximately 90% of atrial ectopies trigger atrial fibrillation originate from the myocardium within the pulmonary vein and that catheter ablation of this origin can cure atrial fibrillation. In recent years, pulmonary vein isolation has become the standard of care. However, a second ablation is required in about 50-60% of cases of persistent atrial fibrillation. A number of additional treatment strategies have been proposed to improve outcomes, including ablation of the atrial fibrillation substrate. However, past prospective randomized studies have failed to demonstrate the efficacy of additional ablations that were previously thought to be effective. One factor has been the inadequate assessment of the atrial fibrillation substrate.
Recently, a system (CARTO FINDER) has become available that allows real-time assessment of electrical excitation within the atrium during atrial fibrillation, and is expected to provide high-performance assessment of the atrial fibrillation substrate. However, no randomized, prospective studies have been reported to date demonstrating that additional ablation of the atrial fibrillation substrate outperforms pulmonary vein isolation alone. Prospective, multicenter, randomized trials are needed to establish the evidence.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Atrial fibrillation and tachycardia free rate
Key secondary outcomes
Adverse events related to ablation procedure, heart failure, ischemic stroke, cardiac death
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
For initial catheter ablation of nonparoxysmal atrial fibrillation, patients will be randomized 1:1 to pulmonary vein isolation alone (Control group) or pulmonary vein isolation plus ablation of the atrial fibrillation substrate as guided by CARTOFINDER.
Interventions/Control_2
For initial catheter ablation of nonparoxysmal atrial fibrillation, patients will be randomized 1:1 to pulmonary vein isolation alone (Control group) or pulmonary vein isolation plus ablation of the atrial fibrillation substrate as guided by CARTOFINDER.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for initial catheter ablation for non-paroxysmal atrial fibrillation and who have consented to the study
Key exclusion criteria
Previous cardiac surgery
Patients who are considered unfit for follow-up
NYHA 4th degree heart failure
Atrial fibrillation due to reversible causes
Contraindication to anticoagulation
Pregnancy
Other cases deemed inappropriate by the attending physician
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Naoyuki |
| Middle name | |
| Last name | Miwa |
Organization
Tsuchiura Kyodo General Hospital
Division name
Heart Rhythm Center
Zip code
3000028
Address
4-1-1 Ootsuno, Tsuchiura, Ibaraki
TEL
029-830-3711
jet_stream0624@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | Miwa |
Organization
Tsuchiura Kyodo General Hospital
Division name
Heart Rhythm Center
Zip code
3000028
Address
4-1-1 Ootsuno, Tsuchiura, Ibaraki
TEL
029-830-3711
Homepage URL
jet_stream0624@yahoo.co.jp
Sponsor or person
Institute
Tsuchiura Kyodo General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Tsuchiura Kyodo Hospital
Address
4-1-1 Ootsuno, Tsuchiura, Ibaraki
Tel
029-830-3711
jet_stream0624@yahoo.co.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
| 2023 | Year | 07 | Month | 05 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2026 | 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
| 2023 | Year | 07 | Month | 05 | Day |
Last modified on
| 2024 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058779
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| Registered date | File name |
| Research case data | |
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