UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049291 |
|---|---|
| Receipt number | R000056137 |
| Scientific Title | Impact of the Novel Sheath VIsualization TechnoloGy on CatHeter Ablation in Treatment of Atrial Fibrillation |
| Date of disclosure of the study information | 2022/10/23 |
| Last modified on | 2024/04/24 15:09:35 |
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Basic information
Public title
Impact of the Novel Sheath VIsualization TechnoloGy on CatHeter Ablation in Treatment of Atrial Fibrillation
Acronym
INSIGHT Study
Scientific Title
Impact of the Novel Sheath VIsualization TechnoloGy on CatHeter Ablation in Treatment of Atrial Fibrillation
Scientific Title:Acronym
INSIGHT Study
Region
| Japan |
Condition
Condition
Paroxysmal atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the real-world impact of the VIZIGO steerable sheath in PAF catheter ablation with respect to procedural efficiency, acute procedural success, clinical effectiveness, and safety. In particular, the study will aim to compare the details and outcomes of PAF catheter ablations performed with or without the VIZIGO steerable sheath.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fluoroscopy time and radiation dose
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Subjects who underwent a de novo radiofrequency ablation for PAF with a Biosense Webster therapeutic catheter at one of the study sites, as follows:
a. from January 2019 to July 2021 with a non-VIZIGO sheath, or
b. from July 2020 to July 2021 with a VIZIGO sheath
2. Subjects have follow up data through 12 months post-index procedure, with the exemption of subjects who have died prior to their 12 month follow up visit
3. Subjects aged 18 years or older on the day of the ablation procedure
4. Willing and capable of providing consent according to the Ethical Guidelines for Life Science and Medical Research Involving Human Subjects
Key exclusion criteria
1. Subjects with history of persistent atrial fibrillation or long standing-persistent AF at the time of the ablation procedure
2. Subjects with any prior left atrial ablation or cardiac-cause surgery before the ablation procedure
3. Subjects who were enrolled in a potentially confounding drug or device trial at the time of their ablation procedure or within the 12-month follow-up period post-procedure
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Okumura |
Organization
Nihon University School of Medicine
Division name
Department of Medicine, Division of Cardiology
Zip code
173-8610
Address
30-1 Oyaguchikamityo, itabashi-ku, Tokyo
TEL
03-3972-8111
okumura.yasuo@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Eri |
| Middle name | |
| Last name | Suzuki |
Organization
Johnson & Johnson K.K CMO office
Division name
Clinical Research
Zip code
101-0065
Address
3-5-2 Nishikanda, Chiyoda-ku, Tokyo
TEL
080-8400-6517
Homepage URL
ESuzuki6@ITS.JNJ.com
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Biosense Webster, Inc.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Itabashi Hospital, Clinical Research Judging Committee
Address
30-1 Oyaguchikamityo, itabashi-ku, Tokyo
Tel
03-3972-8111
med.rinsyokenkyu@nihon-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 | 10 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 10 | Month | 22 | Day |
Last modified on
| 2024 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056137
