UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046550 |
|---|---|
| Receipt number | R000053109 |
| Scientific Title | Clinical outcomes of CARTO FINDER and CFAE (ICL mode) ablation after pulmonary vein isolation for persistent atrial fibrillation |
| Date of disclosure of the study information | 2022/01/05 |
| Last modified on | 2025/02/04 17:31:37 |
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Basic information
Public title
Clinical outcomes of CARTO FINDER and CFAE (ICL mode) ablation after pulmonary vein isolation for persistent atrial fibrillation
Acronym
Clinical outcomes of CARTO FINDER and CFAE (ICL mode) ablation after pulmonary vein isolation for persistent atrial fibrillation
Scientific Title
Clinical outcomes of CARTO FINDER and CFAE (ICL mode) ablation after pulmonary vein isolation for persistent atrial fibrillation
Scientific Title:Acronym
Clinical outcomes of CARTO FINDER and CFAE (ICL mode) ablation after pulmonary vein isolation for persistent atrial fibrillation
Region
| Japan |
Condition
Condition
persistent atrial fibrillation
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clinical outcomes of CARTO FINDER and CFAE (ICL mode) ablation after pulmonary vein isolation for persistent atrial fibrillation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
2) Total number of PACs PAC short run AT(1,3,6,12 months after surgery)
3) Change in resting heart rate from baseline (1,3,6,12 months after surgery)
4) Amount of change from baseline in the following biochemical tests (3,6,12 months after surgery)
Triglyceride, LDL / HDL cholesterol, fatty acid 4 fraction, hemoglobin, hematocrit, cystatin C, renin, aldosterone, Brain natriuretic peptide, Atrial natriuretic peptide, NT-pro BNP
5) Amount of change from baseline in the following echocardiographic findings (3,12 months after surgery)
Left ventricular ejection fraction (LVEF), presence or absence of MR (none, mild, moderate, severe), tricuspid regurgitation pressure gradient (none, mild, moderate, severe), left ventricular end diastolic diameter, left ventricular end systole diameter, Left ventricle diameter
Key secondary outcomes
1) Total number of PACs PAC short run. AT(1,3,6,12 months after surgery)
2) Change in resting heart rate from baseline (1,3,6,12 months after surgery)
3) Amount of change from baseline in the following biochemical tests (3,6,12 months after surgery)
Triglyceride, LDL / HDL cholesterol, fatty acid 4 fraction, hemoglobin, hematocrit, cystatin C, renin, aldosterone, Brain natriuretic peptide, Atrial natriuretic peptide, NT-pro BNP
4) Amount of change from baseline in the following echocardiographic findings (3,12 months after surgery)
Left ventricular ejection fraction (LVEF), presence or absence of MR (none, mild, moderate, severe), tricuspid regurgitation pressure gradient (none, mild, moderate, severe), left ventricular end diastolic diameter, left ventricular end systole diameter, Left ventricle diameter
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
CARTOFINDER+CFAE(ICL mode)ablation
Interventions/Control_2
Pulmonary vein isolation
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
1 Patients with persistent atrial fibrillation during hospital visits who relapsed after 1st ablation
2 Patients who underwent only expanded pulmonary vein isolation in 1st ablation
3 Patients who are indicated for catheter ablation. (Japanese Circulation Society Arrhythmia Drug Treatment Guidelines (Revised 2018)
4 Patients whose age at the time of obtaining consent is 20 to 85 years old
5 Patients who can consent by themselves
Key exclusion criteria
1 Patients who have difficulty in restoring sinus rhythm by cardioversion
2 Patients who do not agree to be the target of this case
3 Patients with persistent atrial fibrillation
4 Other patients who are not qualified by the attending physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Morio |
| Middle name | |
| Last name | Ono |
Organization
Showa University Northern Yokohama Hospital
Division name
Cardiology
Zip code
224-8503
Address
35-1,chigasakichuuou, yokohamashitudukiku,kanagawa
TEL
(+81)45-949-7000
morio.ono@gmail.com
Public contact
Name of contact person
| 1st name | Morio |
| Middle name | |
| Last name | Ono |
Organization
Showa University Northern Yokohama Hospital
Division name
Cardiology
Zip code
224-8503
Address
35-1,chigasakichuuou, yokohamashitudukiku,kanagawa
TEL
(+81)45-949-7000
Homepage URL
morio.ono@gmail.com
Sponsor or person
Institute
Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Department of Cardiology University Northern Yokohama Hospital
Address
35-1,chigasakichuuou, yokohamashitudukiku,kanagawa
Tel
(+81)45-949-7000
morio.ono@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
| 2022 | Year | 01 | 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
Completed
Date of protocol fixation
| 2022 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 05 | Day |
Last modified on
| 2025 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053109
