UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018365 |
|---|---|
| Receipt number | R000021266 |
| Scientific Title | Safety and efficacy of ganglionated plexus ablation in the hemodialysis patients undergoing pulmonary vein isolation for paroxysmal atrial fibrillation |
| Date of disclosure of the study information | 2015/07/21 |
| Last modified on | 2018/06/22 09:44:14 |
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Basic information
Public title
Safety and efficacy of ganglionated plexus ablation in the hemodialysis patients undergoing pulmonary vein isolation for paroxysmal atrial fibrillation
Acronym
Safety and efficacy of ganglionated plexus ablation in the hemodialysis patients undergoing pulmonary vein isolation for paroxysmal atrial fibrillation
Scientific Title
Safety and efficacy of ganglionated plexus ablation in the hemodialysis patients undergoing pulmonary vein isolation for paroxysmal atrial fibrillation
Scientific Title:Acronym
Safety and efficacy of ganglionated plexus ablation in the hemodialysis patients undergoing pulmonary vein isolation for paroxysmal atrial fibrillation
Region
| Japan |
Condition
Condition
Paroxysmal atrial fibrillation
Renal disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the maintenance of sinus rhythm after ganglionated plexus ablation in the end-stage renal disease patients undergoing pulmonary vein isolation for paroxysmal atrial fibrillation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence within one year from the first ablation
Key secondary outcomes
i) Recurrence within one year from the last ablation
ii) Procedure time, fluoroscopic time, complications
iii) Pulmonary congestion necessary to extend hospital stay
iv) Increase in weight after ablation
v) Unscheduled hemodialysis
vi) Cerebral infarction, systemic thromboembolism
vii) All-cause death, cardiac death, sudden death
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Treatment of ganglionated plexus ablation and pulmonary vein isolation before catheter ablation
Interventions/Control_2
Treatment of pulmonary vein isolation before catheter 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
a. Hemodialysis patients who is planning to receive treatment of first catheter ablation for paroxysmal atrial fibrillation
b. Patients who received sufficient explanation, understood it and gave written consent based on their free will, before participating in this study
Key exclusion criteria
a. Patients with non-valvular atrial fibrillation, after open heart surgery
b. NYHA III or IV
c. Peritoneal dialysis patients
d. Patients who were judged inappropriate by the principal investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Furukawa |
Organization
Osaka General Medical Center
Division name
Department of Cardiology
Zip code
Address
3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL
06-6692-1201
kenkyusien@gh.opho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshio Furukawa |
Organization
Osaka General Medical Center
Division name
Department of Cardiology
Zip code
Address
3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL
06-6692-1201
Homepage URL
kenkyusien@gh.opho.jp
Sponsor or person
Institute
Osaka General Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hyogo College of Medicine
Osaka Rosai Hospital
Kansai Rosai Hospital
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
大阪府立急性期・総合医療センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 21 | 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
| 2015 | Year | 01 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2019 | 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
| 2015 | Year | 07 | Month | 21 | Day |
Last modified on
| 2018 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021266
