UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046657 |
|---|---|
| Receipt number | 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 | 2023/09/27 05:48:51 |
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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
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
d216209@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
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
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
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 17 | Day |
Last modified on
| 2023 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052610
