UMIN-CTR Clinical Trial

Basic information
Public title	efficacy and safety of Isochronal late activation mapping guided SVC isolation
Acronym	efficacy and safety of Isochronal late activation mapping guided SVC isolation
Scientific Title	efficacy and safety of Isochronal late activation mapping guided SVC isolation
Scientific Title:Acronym	efficacy and safety of Isochronal late activation mapping guided SVC isolation
Region	Japan

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

Objectives
Narrative objectives1	A conventional method of the superior vena cava (SVC) isolation, which ablate circumferentially the right atrium (RA) and SVC junction line identified by angiography has reported to be associated with several complications such as phrenic nerve or sinus node injury. Thus, we often have cases of difficulty in SVC isolation by the conventional method. Isochronal late activation map (ILAM) is a novel functional substrate mapping technique to identify the critical isthmus of reentrant ventricular arrhythmias. We hypothesized that the ILAM could efficiently identify the SVC sleeve and conduction block line, which would contribute to minimize the procedure time, fluoroscopy time, radiofrequency delivery, and complications. The purpose of this study is to reveal the clinical utility and feasibility of ILAM in SVC isolation compared to the conventional method.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The completion rate of SVC isolation
Key secondary outcomes	Procedure time (time from the start of SVC isolation to the completion of isolation), fluoroscopy time, number of RF deliveries, total RF energy, complications (phrenic nerve injury, sinus node injury, SVC stenosis, cardiac tamponade)

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	Maneuver
Interventions/Control_1	The electroanatomical maps of SVC and RA during sinus rhythm are constructed by high-density mapping catheter (AdvisorTM HD Grid Mapping Catheter, Abbott, St. Paul, MN) and EnSite X system (Abbott, St. Paul, MN). The location of SVC sleeve and RA-SVC conduction block line are identified by using the ILAM. Radiofrequency applications are delivered along the line connecting the ends of conduction block lines. The procedure success of SVC isolation is defined as a bidirectional block between the SVC and the RA.
Interventions/Control_2	SVC angiography is performed to identify anatomical RA-SVC junction. RF applications are delivered along circumferential line beyond the RA-SVC junction. The procedure success of SVC isolation is defined as a bidirectional block between the SVC and the RA.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who undergo catheter ablation for atrial fibrillation and meet the following conditions. ･ 2nd session ･ Persistent atrial fibrillation ･ Suspected SVC origin PAC inducing AF
Key exclusion criteria	･ Under 20 years old ･ Patients undergoing SVC isolation at the time of initial treatment ･ Patients with a pacemaker or bradyarrhythmia ･ Patients with initial treatment of catheter ablation for paroxysmal atrial fibrillation with no evidence of atrial fibrillation induced by PAC originating from SVC ･ Patients with poor SVC potential and no SVC sleeve length ･ Others who are deemed inappropriate by the investigator or the research coordinator
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Yukiko Middle name Last name Nakano
Organization	Hiroshima University Graduate School of Biomedical and Health Sciences
Division name	Department of Cardiovascular Medicine
Zip code	734-8551
Address	1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima Prefecture
TEL	082-257-5540
Email	nakanoy@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Naoto Middle name Last name Oguri
Organization	Hiroshima University Graduate School of Biomedical and Health Sciences
Division name	Department of Cardiovascular Medicine
Zip code	734-8551
Address	1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima Prefecture
TEL	082-257-5540
Homepage URL
Email	d216209@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

Funding Source
Organization	Hiroshima University
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	Center for integrated medical research
Address	1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima Prefecture
Tel	082-257-5596
Email	hugcp@hiroshima-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	2022 Year 01 Month 20 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	2021 Year 11 Month 12 Day
Date of IRB	2021 Year 12 Month 16 Day
Anticipated trial start date	2022 Year 01 Month 20 Day
Last follow-up date	2023 Year 12 Month 31 Day
Date of closure to data entry	2023 Year 12 Month 31 Day
Date trial data considered complete	2023 Year 12 Month 31 Day
Date analysis concluded	2024 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2022 Year 01 Month 17 Day
Last modified on	2022 Year 01 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052610

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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