UMIN-CTR Clinical Trial

Basic information
Public title	The distribuiton of inflamation aseesed by the PETMRI after cryoballoon ablation and AF recurrence
Acronym	Visulaization of inflamation after cryoballoon ablation by the PETMRI
Scientific Title	The distribuiton of inflamation aseesed by the PETMRI after cryoballoon ablation and AF recurrence
Scientific Title:Acronym	Visulaization of inflamation after cryoballoon ablation by the PETMRI
Region	Japan

Condition
Condition	atrial fibrillation
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aim to clarify whether the degree of inflamation assessed by the PETMRI could be associated with the atrial fibrillaiton recurrence.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Quantitative analysis of the inflamation induced by cryoballoon albaiton
Key secondary outcomes	atrial fibrillation reucrrence

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	PETMRI was peformed 3days after cryoballoon ablation to assess the degree of inflamation induced by the ablation procedure.
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	20 years-old <
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Prospective interventional study The patients who underewnet cyoballoon ablation for the atrial fibrillation.
Key exclusion criteria	The patients with brochial asthma, chronic kidney disase (eGFR<45 mL/min/1.73m2) and who underwent hemodialysis.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Koji Middle name Last name Fukuzawa
Organization	Department of Internal Medicine, Kobe University Graduate School of Medcine
Division name	Division of Cardiovascular Medicine
Zip code	650-0017
Address	7-5-2 Kusunokicho, Chuo-ku, Kobe, Hyogo
TEL	078-382-5111
Email	kfuku@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Kunihiko Middle name Last name Kiuchi
Organization	Department of Internal Medicine, Kobe University Graduate School of Medcine
Division name	Division of Cardiovascular Medicine
Zip code	650-0017
Address	7-5-2 Kusunokicho, Chuo-ku, Kobe, Hyogo
TEL	078-382-5111
Homepage URL
Email	kunihikokiuchi@yahoo.co.jp

Sponsor
Institute	Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medcine
Institute
Department

Funding Source
Organization	Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medcine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Radiology, Kobe University Graduate School of Medcine
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Ethics Committee at Kobe university hospital
Address	7-5-2 Kusunokicho, Chuo-ku, Kobe, Hyogo
Tel	078-382-6669
Email	kainyu@med.kobe-u.ac.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	2017 Year 07 Month 01 Day

Related information
URL releasing protocol	http://dx.doi.org/10.1002/joa3.12454
Publication of results	Published

Result
URL related to results and publications	http://dx.doi.org/10.1002/joa3.12454
Number of participants that the trial has enrolled	10
Results	SUV max on the PV antrum was significantly higher than that on the healthy LA wall. The volume of the atrial inflammation was strongly correlated with that of the atrial fibrosis.
Results date posted	2020 Year 05 Month 21 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 11 Month 19 Day
Baseline Characteristics	A consecutive 10 paroxysmal atrial fibrillation patients after the cryoballoon ablation (CBA) were enrolled. The patient characteristics are shown in Table 1. The mean age was 54 +/- 15 years old and 9 patients were male. The mean left atrial diameter (LAD) and left ventricular ejection fraction (LVEF) were 38 +/- 6 mm and 62 +/- 9 %, respectively. As for the procedural data, the CBA procedure time and fluoroscopy time were 167 +/- 38 min and 46 +/- 20 mm, respectively. Radiofrequency touch-up ablation for the RIPV was performed in 1 (10%) of 10 patients. The cardiac rhythm was sinus rhythm (SR) at the time of the PET/MRI and LGE-MRI acquisition in all patients.
Participant flow	This study was an open-label, single-arm, prospective clinical trial and was registered with the University Hospital Medical Information Network-Clinical Trial Registry (UMIN-CTR) (UMIN000027417) and Japan Registry of Clinical Trials (jRCT) (jRCTs 052180024). The protocol for this study was approved by the local ethics committees of the institutions and conformed to the provisions of the Declaration of Helsinki (Committee of 17 August 2019, Approval No.C180014).The detailed protocol has been described previously.(7) The primary endpoint was the visualization of the atrial inflammation by the PET/MRI. The secondary endpoint was the atrial fibrosis following atrial inflammation.
Adverse events	No adverse events.
Outcome measures	We assess whether the atrial inflammation caused by CBA could be visualized by PET/MRI and whether it was associated with the followingfibrosis in AF patients.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 18 Day
Date of IRB	2017 Year 12 Month 15 Day
Anticipated trial start date	2018 Year 05 Month 01 Day
Last follow-up date	2019 Year 09 Month 30 Day
Date of closure to data entry	2019 Year 12 Month 10 Day
Date trial data considered complete	2019 Year 12 Month 15 Day
Date analysis concluded	2019 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 05 Month 19 Day
Last modified on	2020 Year 11 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030960

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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