UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022119 |
|---|---|
| Receipt number | R000025392 |
| Scientific Title | Substrate Targeted Ablation of Persistent Atrial Fibrillation Trial |
| Date of disclosure of the study information | 2016/07/14 |
| Last modified on | 2017/03/13 11:05:23 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Substrate Targeted Ablation of Persistent Atrial Fibrillation Trial
Acronym
START Trial
Scientific Title
Substrate Targeted Ablation of Persistent Atrial Fibrillation Trial
Scientific Title:Acronym
START Trial
Region
| Japan |
Condition
Condition
Persistent Atrial Fibrillation Patients
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety and efficacy of left atrial low voltage zone ablation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acute teremination of atrisl fibrillation, long term success, and complications after left atrial low voltage zone ablation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Pulmonary vein antrum isolation (PVAI) and Left atrial low voltage zone (LVZ) ablation for patients with LVZ.
Interventions/Control_2
PVAI only for patients with LVZ.
Interventions/Control_3
PVAI for patients without LVZ.
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
Persistent atrial fibrillation patient who is undergoing initial atrial fibrillation ablation.
Key exclusion criteria
Patients with low cardiac function, left atrial thrombus, contraindication of anticoagulant therapy.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuchiya Takeshi |
Organization
EP Expert Doctors-Team Tsuchiya
Division name
Electrophysiology
Zip code
Address
Koto 3-14-28, Higashi-ku, Kumamoto
TEL
096-368-0403
tsuchiya0210jupiter@yj8.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fukui Akira |
Organization
EP Expert Doctors-Team Tsuchiya
Division name
Electrophysiology
Zip code
Address
Hirogi-machi 30-35-102, Higashi-ku, Kumamoto
TEL
090-2513-7156
Homepage URL
akira18@oita-u.ac.jp
Sponsor or person
Institute
EP Expert Doctors-Team Tsuchiya
Institute
Department
Personal name
Funding Source
Organization
START Trial Meeting
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 | 07 | Month | 14 | 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
Date of protocol fixation
| 2015 | Year | 07 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 30 | 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 | 04 | Month | 28 | Day |
Last modified on
| 2017 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025392
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
