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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Atrial fibrillation | |
Classification by specialty |
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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 |
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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 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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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 |
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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 |
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Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Hiroshima University |
Institute | |
Department |
Funding Source | |
Organization | Hiroshima University |
Organization | |
Division | |
Category of Funding Organization | Self funding |
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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 |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
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Recruitment status | Open public recruiting | ||||||
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Last modified on |
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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 | |
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Research case data | |
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