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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008439
Receipt No. 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

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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
Email 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
Email Jun_Miyakawa@nts.toray.co.jp

Sponsor
Institute Toray Industries, Inc.
Institute
Department

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
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
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
URL(English) https://upload.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


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