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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046657
Receipt No. R000052610
Scientific Title efficacy and safety of Isochronal late activation mapping guided SVC isolation
Date of disclosure of the study information 2022/01/20
Last modified on 2022/01/20

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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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