UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018461 |
|---|---|
| Receipt number | R000021380 |
| Scientific Title | Comparative evaluation of cellular damages and inflammatory responses between cryoballoon catheter ablation and radiofrequency catheter ablation for patients with atrial fibrillation |
| Date of disclosure of the study information | 2015/07/28 |
| Last modified on | 2015/07/31 17:37:16 |
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Basic information
Public title
Comparative evaluation of cellular damages and inflammatory responses between cryoballoon catheter ablation and radiofrequency catheter ablation for patients with atrial fibrillation
Acronym
Comparative evaluation between cryoballoon catheter ablation and radiofrequency catheter ablation for patients with atrial fibrillation
Scientific Title
Comparative evaluation of cellular damages and inflammatory responses between cryoballoon catheter ablation and radiofrequency catheter ablation for patients with atrial fibrillation
Scientific Title:Acronym
Comparative evaluation between cryoballoon catheter ablation and radiofrequency catheter ablation for patients with atrial fibrillation
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to investigate whether there are the differences of cellular damages, inflammatory responses, oxidative stress, and anticoagulation between cryoballoon catheter and radiofrequency catheter for patients with atrial fibrillation after catheter ablation.
Basic objectives2
Others
Basic objectives -Others
We also aimed to evaluate the predictive biomarkers for recurrence of atrial fibrillation during study periods.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Degree of cardiac injury (Troponin I)
Key secondary outcomes
The presence or absence of recurrence of atrial fibrillation during study periods.
Time taken to treatment with catheter ablation.
Components of Examination
(CK, CK-MB, Troponin T, HFBP, vWF, thrombomodulin, P-selectin, Endothelin-1, WBC(Neutrophil), CRP, Serum amyloid A, E-selectin, PTX3, sCD40L, ferritin, IL-6, IL-8, TNF-alpha, TGF-beta, IL-4, IL-10, GDF15, D-dimer, TAT, PIC, HANP, BNP, NT Pro-BNP, MDA-LDL, 8-OHdG, MMP-2, TIMP-2, s-FasL)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Interventions: Cryoballoon catheter group
Arctic Front Advance or Freezor MAX cryoballoon catheter
Interventions/Control_2
Control: radiofrequency catheter group
NaviStar ThermoCool ablation catheter
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Study subjects are atrial fibrillation patients (20-79 years old) who will undergo catheter ablation in University of Tsukuba Hospital, and give written informed consent for the study.
Key exclusion criteria
(1) severe LV dysfunction (LVEF < 35%)
(2) severe mitral valve stenosis
(3) severe atrial valve stenosis
(4) open cardiac surgery within 3 months
(5) percutaneous coronary intervention within 1 months
(6) renal failure patients with hemodialysis
(7) severe anemia (hemoglobin < 10g/dl in men, <9g/dl in women)
(8) complicated with atrial flutter, supraventricular tachycardia, and ventricular tachycardia who are needed to undergo catheter ablation
(9) patients who are likely to have poor prognosis such as terminal cancer
(10) contraindication for catheter ablation (ex. left atrial appendage thrombosis)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazutaka Aonuma |
Organization
University of Tsukuba
Division name
Cardiovascular Division, Faculty of Medicine
Zip code
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki, Japan
TEL
029-853-3142
kaonuma@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Murakoshi |
Organization
University of Tsukuba
Division name
Cardiovascular Division, Faculty of Medicine
Zip code
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki, Japan
TEL
029-853-3142
Homepage URL
n.murakoshi@md.tsukuba.ac.jp
Sponsor or person
Institute
Cardiovascular Division, Faculty of Medicine, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Medtronic Japan Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
筑波大学（茨城県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 28 | 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
| 2015 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 28 | Day |
Last modified on
| 2015 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021380
