UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027200 |
|---|---|
| Receipt number | R000031168 |
| Scientific Title | Evaluation of exercise tolerance between before and after catheter ablation of atrial fibrillation |
| Date of disclosure of the study information | 2017/05/01 |
| Last modified on | 2025/05/21 13:15:49 |
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Basic information
Public title
Evaluation of exercise tolerance between before and after catheter ablation of atrial fibrillation
Acronym
Evaluation of exercise tolerance between before and after catheter ablation of atrial fibrillation
Scientific Title
Evaluation of exercise tolerance between before and after catheter ablation of atrial fibrillation
Scientific Title:Acronym
Evaluation of exercise tolerance between before and after catheter ablation of atrial fibrillation
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate change of exercise tolerance in cardiopulmonary exercise testing after catheter ablation of atrial fibrillation
Basic objectives2
Others
Basic objectives -Others
prospective observational study
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
exercise tolerance (before and after 1 to 6 months)
Key secondary outcomes
cardiac function (before and after 6 months)
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who will undergo catheter ablation of atrial fibrillation
Key exclusion criteria
hemodialysis
systolic blood pressure <80mmHg
heart rate <50bpm
LV EF<=35%
patients with pacemaker, ICD, CRT
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shigeto |
| Middle name | |
| Last name | Naito |
Organization
Gunma Prefectural Cardiovascular Center
Division name
Division of Cardiology
Zip code
371-0004
Address
3-12 Kameizumi-machi, Maebashi City, Gunma
TEL
027-269-7455
shigeto@tohgoku.or.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Take |
Organization
Gunma Prefectural Cardiovascular Center
Division name
Division of Cardiology
Zip code
371-0004
Address
3-12 Kameizumi-machi, Maebashi City, Gunma
TEL
027-269-7455
Homepage URL
take-6@umin.ac.jp
Sponsor or person
Institute
Gunma Prefectural Cardiovascular Center
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
Gunma Prefectural Cardiovascular Center
Address
3-12 Kameizumi-machi, Maebashi City, Gunma
Tel
027-269-7455
take-6@umin.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
群馬県立心臓血管センター(群馬県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate exercise tolerance,
cardiopulmonary exercise testing is performed 2 times before and after catheter ablation(1-12months)
Management information
Registered date
| 2017 | Year | 04 | Month | 30 | Day |
Last modified on
| 2025 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031168
