UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048658 |
|---|---|
| Receipt number | R000053562 |
| Scientific Title | Comparison of microembolic signals on carotid artery Doppler ultrasound between high power and low power setting during radiofrequency catheter ablation for atrial fibrillation |
| Date of disclosure of the study information | 2022/08/12 |
| Last modified on | 2023/12/25 17:44:49 |
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Basic information
Public title
Comparison of microembolic signals on carotid artery Doppler ultrasound between high power and low power setting during radiofrequency catheter ablation for atrial fibrillation
Acronym
Comparison of microembolic signals on carotid artery Doppler ultrasound between high power and low power setting during radiofrequency catheter ablation for atrial fibrillation
Scientific Title
Comparison of microembolic signals on carotid artery Doppler ultrasound between high power and low power setting during radiofrequency catheter ablation for atrial fibrillation
Scientific Title:Acronym
Comparison of microembolic signals on carotid artery Doppler ultrasound between high power and low power setting during radiofrequency catheter ablation for atrial fibrillation
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate microembolic signals during radiofrequency catheter ablation
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of microembolic signals and microbubble signals
Key secondary outcomes
Size of microembolic signals, changes in coagulation markers, clinical embolic events, MMSE score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
High power short duration ablation
Interventions/Control_2
Low power long duration ablation
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 scheduled for radiofrequency catheter ablation of AF
Required ablation for pulmonary vein isolation and tricuspidisthmus ablation only
Adequate evaluation on carotid artery Doppler ultrasound
Stable condition with sufficient collection of the coagulation marker preoperatively
Therapeutic range of the PT-INR in patients taking warfarin
Key exclusion criteria
Required additional extensive ablation in left atrium
Hematologic disease and those patients with chemotherapy
A history of major surgery and active inflammatory disease within 1 month
Antiplatelet drug administration
Severe atherosclerosis in aorta and carotid artery
Inapplicable to include the study by an attending doctor
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Toyoaki |
| Middle name | |
| Last name | Murohara |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
466-8550
Address
65, Tsurumai-cho, showa-ku, Nagoya, Aichi
TEL
81527442148
murohara@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Yanagisawa |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Advanced Cardiovascular Therapeutics
Zip code
466-8550
Address
65, Tsurumai-cho, showa-ku, Nagoya, Aichi
TEL
81527442148
Homepage URL
yanagisawa-sato@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine, Department of Cardiology
Institute
Department
Personal name
Funding Source
Organization
None
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
The Nagoya University Ethics Committee
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi4668550, Japan.
Tel
81-52-744-2423
ethics@med.nagoya-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
名古屋大学医学部附属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 12 | 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
| 2022 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 12 | Day |
Last modified on
| 2023 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053562
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
