UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023100 |
|---|---|
| Receipt number | 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 15:53:33 |
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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
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
kawaji@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine,
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026626
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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