UMIN-CTR Clinical Trial

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

Contact us.