UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026848 |
|---|---|
| Receipt number | R000021668 |
| Scientific Title | A Tailor-made Durable Ablation Strategy for Atrial Fibrillation Based on the PV Antrum Wall Thickness |
| Date of disclosure of the study information | 2017/04/04 |
| Last modified on | 2019/10/05 10:17:00 |
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Basic information
Public title
A Tailor-made Durable Ablation Strategy for Atrial Fibrillation Based on the PV Antrum Wall Thickness
Acronym
Force-time Integral / Wall Thickness (FTIW) Based PVI Ablation Strategy
Scientific Title
A Tailor-made Durable Ablation Strategy for Atrial Fibrillation Based on the PV Antrum Wall Thickness
Scientific Title:Acronym
Force-time Integral / Wall Thickness (FTIW) Based PVI Ablation Strategy
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the incidence of pulmonary vein dormant conduction by adenosine triphosphate and the recurrence rate of atrial fibrillation after pulmonary vein isolation based on a pulmonary vein atrum wallthickness
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Incidence of pulmonary vein dormant conduction
2. Atrial fibrillation recurrence rate in the short- and long-term period after ablation
Key secondary outcomes
1. Incidence of ipsilateral pulmonary vein isolation
2. Complication rate
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Atrial fibrillation
Key exclusion criteria
History of stroke and remote myocardial infarction within 3 months
Presence of left atrial thrombosis
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Okumura |
Organization
Division of Cardiology, Department of Medicine, Nihon University School of Medicine
Division name
Nihon University Itabashi Hospital
Zip code
1738610
Address
30-1 Ohyaguchi, Kamicho, Itabashi-Ku, Tokyo 173-8610, Japan
TEL
+81-3-3972-8111
yasuwo128@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yasuo |
| Middle name | |
| Last name | Okumura |
Organization
Nihon University Itabashi Hospital
Division name
Division of Cardiology
Zip code
1738610
Address
30-1 Ohyaguchi, Kamicho, Itabashi-Ku, Tokyo 173-8610, Japan
TEL
+81-3-3972-8111
Homepage URL
yasuwo128@yahoo.co.jp
Sponsor or person
Institute
Division of Cardiology, Department of Medicine, Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Cardiology, Department of Medicine, Nihon University School of Medicine
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
Nihon University Itabashi Hospital Clinical Research Center
Address
30-1 Oyaguchi-Kami Itabashi-Ku
Tel
0339728111
komoda.nozomi@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
| 2017 | Year | 04 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2016 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
64 patients were enrolled. A subalanysis of this study was published in Journal of interventional cardiac electrophysiology
Management information
Registered date
| 2017 | Year | 04 | Month | 03 | Day |
Last modified on
| 2019 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021668
