UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Single-center Prospective Randomized Controlled Trial Evaluating Efficacy and Safety of Catheter Ablation without Periprocedual Contrast Media for Paroxysmal Atrial Fibrillation: Sophisticated Atrial Fibrillation ablation procedurE contrasT media unnecessitY (SAFETY) trial
Title of the study (Brief title)	SAFETY trial
Region	Japan

Condition
Condition	Paroxysmal atrial fibrillation
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the efficacy and safety of catheter ablation without periprocedual contrast media for paroxysmal atrial fibrillation compared with conventional strategy with contrast media.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Event-free rate from atrial tachyarrhythmia after procedure
Key secondary outcomes	Any procedural complications Total time required for mapping of left atrium during procedure Total procedure time Total fluoroscopy time Total radiation dose Total number of energy applications Incidence of dormant conduction Renal function after procedur

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients are randomized in a 1:1 ratio to catheter ablation for paroxysmal atrial fibrillation with or without periprocedual contrast media. In contrast group,contrast media was used for 3D mapping left atrium in computed tomography before procedure and left atrium angiography during procedure.
Interventions/Control_2	In group without contrast, contrast media was not used during computed tomography before procedure and during procedure.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients undergoing first catheter ablation for paroxysmal atrial fibrillation, who are 20-80 years old, able to be followed for one year in an out-patient clinic and willing to sign the consent form for participation, are eligible for the study.
Key exclusion criteria	1) Patients with a history of allergy for contrast media 2) Patients with renal insufficiency (eGFR <=45ml/min/1.73m2 3) Left ventricular ejection fraction < 40% 4) Left atrial diameter > 50mm 5) Patients with a history of open heart surgery 6) Patients with moderate or severe valve heart disease 7) Patients who need additional ablation such as tricuspid valve isthmus ablation during procedure 8) Patients unwilling to sign the consent form for participation
Target sample size	100

Research contact person
Name of lead principal investigator	Satoshi Shizuta
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Cardiology
Address	54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507 Japan
TEL	075-751-4255
Email	shizuta@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Tetsuma Kawaji
Organization	Kyoto University Graduate School of Medicine,
Division name	Department of Cardiology
Address	54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507 Japan
TEL	075-751-4255
Homepage URL
Email	kawaji@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Graduate School of Medicine,
Institute
Department

Funding Source
Organization	Kyoto University Graduate School of Medicine,
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 10 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 09 Month 10 Day
Anticipated trial start date	2016 Year 09 Month 10 Day
Last follow-up date
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	2016 Year 07 Month 11 Day
Last modified on	2016 Year 08 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026626