UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008439 |
|---|---|
| Receipt number | R000009926 |
| Scientific Title | A Pivotal Study of TSB-002C for the Treatment of Paroxysmal Atrial Fibrillation |
| Date of disclosure of the study information | 2012/07/15 |
| Last modified on | 2015/02/18 17:15:37 |
* 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
A Pivotal Study of TSB-002C for the Treatment of Paroxysmal Atrial Fibrillation
Acronym
A Pivotal Study of TSB-002C for the Treatment of Paroxysmal Atrial Fibrillation
Scientific Title
A Pivotal Study of TSB-002C for the Treatment of Paroxysmal Atrial Fibrillation
Scientific Title:Acronym
A Pivotal Study of TSB-002C for the Treatment of Paroxysmal Atrial Fibrillation
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 pivotal study is to collect safety and effectiveness data evaluating TSB-002C (NTA-2C, SRF-2C, DGS-1) comparing antiarrhythmic drug therapy when used to treat subjects with paroxysmal atrial fibrillation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary Efficacy Endpoints
Comparison of the rate of long-term success between clinical device arm and antiarrhythmic drug therapy arm.
Safety Endpoints
Adverse event
Clinical device malfunction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Ablation using TSB-002C
Interventions/Control_2
Antiarrhythmic drug therapy
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
[Tentative registration]
(1) Subject is >=20 and <75 years old.
(2) Subject has been diagnosed with symptomatic paroxysmal AF.
(3) Subject has failed to respond to or is intolerant of at least one Class I, II, III orIV AAD. ("Intolerant" is defined as having suffered a clinically significant adverse drug effect.
(4) Subject is able and willing to provide informed consent.
[Formal Registration]
(5) Subject has at least two AF episodes in the 6 months preceding informed consent.
(6) Subject has at least one documented AF episode via ECG, event monitor, or holter monitor in the 6 months proceding informed consent.
Key exclusion criteria
[Tentative Registration]
(1) Subject has undergone previous LA ablation or surgical treatment for AF.
(2) Subject is resistant or intolerant to all of pilsicainide, cibenzoline, propafenone, disopyramide, and flecainide.
(3) Subject is in New York Heart Association (NYHA) Class III or IV.
(4) Subject has a history of myocardial infarction (MI) or unstable angina
within six months prior to enrollment.
(5) Subject has a known history of severe ischemic heart disease or valvular disease.
(6) Subject has left atrial appendage occlusion device.
(7) Subject has severe pulmonary arterial hypertension.
(8) Subject has an artificial heart valve.
(9) Subject has a pacemaker and/or implantable cardiodefibrillator (ICD) and/or implantable loop recorder.
(10) Subject has a history of cerebrovascular disease, including cerebral vascular accident (CVA) or transient ischemic attack (TIA) within six months prior to enrollment.
(11) Subject has a known history of severe obstructive carotid artery disease.
(12) Subject has an inferior vena cava (IVC) filter.
(13) Subject has a known and unresolved deep vein thrombus (DVT).
(14) Subject has significant renal failure.
(15) Subject has a known history of a bleeding disorder related to hemophilia, leukemia, or lymphoma etc.
(16) Subject cannot take any anticoagulant drug.
(17) Subject has abnormal thyroid function and judged to be unsuitable for participation in the study by
the investigator.
(18) Subject has a documented allergy to iodine or iodine contrast media.
(19)(20)(21)(22) --
(23) Subject has been judged to be unsuitable for participation in the study by the investigator for any other reason.
[Formal Registration]
(47) Subject has a left atrium > 50 mm.
(48) Subject has a left ventricular ejection fraction (LVEF) < 35%.
(49) Subject has a left atrial thrombus.
(50) Subject has been judged to be unsuitable for participation in the study by the investigator for any other reason.
Target sample size
111
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Miyakawa |
Organization
Toray Industries, Inc.
Division name
Medical Devices Clinical Research Dept.
Zip code
Address
1-1, Nihonbashi-muromachi 2-chome, Chuo-ku, Tokyo 103-8666, JAPAN
TEL
03-3245-8589
Jun_Miyakawa@nts.toray.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Miyakawa |
Organization
Toray Industries, Inc.
Division name
Medical Devices Clinical Research Dept.
Zip code
Address
1-1, Nihonbashi-muromachi 2-chome, Chuo-ku, Tokyo 103-8666, JAPAN
TEL
03-3245-8589
Homepage URL
Jun_Miyakawa@nts.toray.co.jp
Sponsor or person
Institute
Toray Industries, Inc.
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
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
| 2012 | Year | 07 | Month | 15 | 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
Completed
Date of protocol fixation
| 2012 | Year | 07 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 23 | 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
| 2012 | Year | 07 | Month | 15 | Day |
Last modified on
| 2015 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009926
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
