UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025965 |
|---|---|
| Receipt number | R000029443 |
| Scientific Title | General anesthesia improves contact force and reduces gap formation in pulmonary vein isolation: a comparison with conscious sedation |
| Date of disclosure of the study information | 2017/02/03 |
| Last modified on | 2017/02/02 10:14:04 |
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Basic information
Public title
General anesthesia improves contact force and reduces gap formation in pulmonary vein isolation: a comparison with conscious sedation
Acronym
General anesthesia improves contact force in pulmonary vein isolation
Scientific Title
General anesthesia improves contact force and reduces gap formation in pulmonary vein isolation: a comparison with conscious sedation
Scientific Title:Acronym
General anesthesia improves contact force in pulmonary vein isolation
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to evaluated the influence of GA on contact-force parameters, FTI, FTI/wall thickness and GAP formation during ipsilateral PVI when compared to CS.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluated the influence of GA on contact-force parameters, FTI, FTI/wall thickness and GAP formation during ipsilateral PVI when compared to CS.
Key secondary outcomes
Long-term outcome after ablation
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)symptomatic, drug-refractory AF, referred to kanazawa medical centerl between August 2014 and March 2016 for their first RF catheter ablation procedure
2)Patients who underwent anatomical ipsilateral PVI
Key exclusion criteria
We exclude patients who received catheter ablation without anatomocai CT merge
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Chikata |
Organization
National Hospital Organization, Kanazawa Medical Center
Division name
Department of Cardiology
Zip code
Address
1-1 shimoishibimki-machi, Kanazawa
TEL
076-262-4161
akio.chikata@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akio Chikata |
Organization
National Hospital Organization, Kanazawa Medical Centerr
Division name
Department of Cardiology
Zip code
Address
1-1 shimoishibimki-machi, Kanazawa
TEL
076-262-4161
Homepage URL
akio.chikata@gmail.com
Sponsor or person
Institute
National Hospital Organization, Kanazawa Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization, Kanazawa Medical Center
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
Address
Tel
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
| 2017 | Year | 02 | Month | 03 | 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
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We retrospectively assessed CF parameters, force time integral and FTI/wall thickness during anatomical ipsilateral PVI
Management information
Registered date
| 2017 | Year | 02 | Month | 02 | Day |
Last modified on
| 2017 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029443
