Unique ID issued by UMIN | UMIN000046657 |
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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 |
efficacy and safety of Isochronal late activation mapping guided SVC isolation
efficacy and safety of Isochronal late activation mapping guided SVC isolation
efficacy and safety of Isochronal late activation mapping guided SVC isolation
efficacy and safety of Isochronal late activation mapping guided SVC isolation
Japan |
Atrial fibrillation
Cardiology |
Others
NO
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.
Safety,Efficacy
The completion rate of SVC isolation
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)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Maneuver |
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.
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.
20 | years-old | <= |
Not applicable |
Male and Female
Patients who undergo catheter ablation for atrial fibrillation and meet the following conditions.
・ 2nd session
・ Persistent atrial fibrillation
・ Suspected SVC origin PAC inducing AF
・ 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
200
1st name | Yukiko |
Middle name | |
Last name | Nakano |
Hiroshima University Graduate School of Biomedical and Health Sciences
Department of Cardiovascular Medicine
734-8551
1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima Prefecture
082-257-5540
nakanoy@hiroshima-u.ac.jp
1st name | Naoto |
Middle name | |
Last name | Oguri |
Hiroshima University Graduate School of Biomedical and Health Sciences
Department of Cardiovascular Medicine
734-8551
1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima Prefecture
082-257-5540
d216209@hiroshima-u.ac.jp
Hiroshima University
Hiroshima University
Self funding
Center for integrated medical research
1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima Prefecture
082-257-5596
hugcp@hiroshima-u.ac.jp
NO
2022 | Year | 01 | Month | 20 | Day |
Unpublished
Open public recruiting
2021 | Year | 11 | Month | 12 | Day |
2021 | Year | 12 | Month | 16 | Day |
2022 | Year | 01 | Month | 20 | Day |
2024 | Year | 12 | Month | 31 | Day |
2024 | Year | 12 | Month | 31 | Day |
2024 | Year | 12 | Month | 31 | Day |
2025 | Year | 03 | Month | 31 | Day |
2022 | Year | 01 | Month | 17 | Day |
2023 | Year | 09 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052610
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