UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy of ganglionated plexus ablation in the hemodialysis patients undergoing pulmonary vein isolation for paroxysmal atrial fibrillation
Title of the study (Brief title)	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	Yoshio Furukawa
Organization	Osaka General Medical Center
Division name	Department of Cardiology
Address	3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL	06-6692-1201
Email	kenkyusien@gh.opho.jp

Public contact
Name of contact person	Yoshio Furukawa
Organization	Osaka General Medical Center
Division name	Department of Cardiology
Address	3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL	06-6692-1201
Homepage URL
Email	kenkyusien@gh.opho.jp

Sponsor
Institute	Osaka General Medical Center
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021266