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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000023100
Receipt No. R000026626
Scientific Title 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
Date of disclosure of the study information 2016/09/10
Last modified on 2016/08/30

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Basic information
Public title 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
Acronym SAFETY trial
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Satoshi Shizuta
Organization Kyoto University Graduate School of Medicine
Division name Department of Cardiology
Zip code
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
1st name
Middle name
Last name Tetsuma Kawaji
Organization Kyoto University Graduate School of Medicine,
Division name Department of Cardiology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Terminated
Date of protocol fixation
2016 Year 09 Month 10 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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