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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046550
Receipt No. R000053109
Scientific Title Randomized controlled trial using CARTO FINDER for persistent atrial fibrillation with recurrence after pulmonary vein isolation
Date of disclosure of the study information 2022/01/05
Last modified on 2022/01/14

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Basic information
Public title Randomized controlled trial using CARTO FINDER for persistent atrial fibrillation with recurrence after pulmonary vein isolation
Acronym Randomized controlled trial using CARTO FINDER for persistent atrial fibrillation with recurrence after pulmonary vein isolation
Scientific Title Randomized controlled trial using CARTO FINDER for persistent atrial fibrillation with recurrence after pulmonary vein isolation
Scientific Title:Acronym Randomized controlled trial using CARTO FINDER for persistent atrial fibrillation with recurrence after pulmonary vein isolation
Region
Japan

Condition
Condition Randomized controlled trial using CARTO FINDER for persistent atrial fibrillation with recurrence after pulmonary vein isolation
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Randomized controlled trial of CARFTOFINDER + SVC isolation and BOX isolation + sSVC isolation
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 ablation
Interventions/Control_2 BOX 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
Email 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
Email morio.ono@gmail.com

Sponsor
Institute Showa University Northern Yokohama Hospital
Institute
Department

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
Email 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 Open public recruiting
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
2022 Year 01 Month 14 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053109

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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