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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004409
Receipt No. R000004521
Scientific Title A Pilot Study of TSB-002 for the Treatment of Atrial Fibrillation
Date of disclosure of the study information 2010/10/19
Last modified on 2012/04/09

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Basic information
Public title A Pilot Study of TSB-002 for the Treatment of Atrial Fibrillation
Acronym A Pilot Study of TSB-002 for the Treatment of Atrial Fibrillation
Scientific Title A Pilot Study of TSB-002 for the Treatment of Atrial Fibrillation
Scientific Title:Acronym A Pilot Study of TSB-002 for the Treatment of Atrial Fibrillation
Region
Japan

Condition
Condition Paroxysmal or persistent atrial fibrillation
Classification by specialty
Cardiology Operative medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this pilot study is to collect preliminary safety and effectiveness data evaluating the TSB-002 (NTA-2,SRF-1,DGS-1) when used to treat subjects with symptomatic paroxysmal or persistent atrial fibrillation (AF).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary Safety Endpoints
(1)The occurrence of Major Complications will be assessed through the 6-month follow-up visit.
Major Complications are defined as:
- An SAE within seven days of the post ablation procedure;
- Severe PV stenosis (>70%) or esophageal fistula that occurs any time after the ablation procedure;
- Mild (<50%) or moderate (50-70%) PV stenosis that occurs any time after the ablation procedure and meets one of the following criteria:
--Requires an invasive intervention, such as PV stenting or
--Results in clinically significant symptoms.

Primary Efficacy Endpoints
(1)The rate of acute procedural success will be calculated. Acute procedural success is defined as evidence of PV electrical potential elimination (PV electrogram amplitude < 0.1 mV) or LA-PV (left atrial-pulmonary vein) dissociation of all treated pulmonary veins at the time of procedure.
(2)The rate of long-term success through 12-month follow-up. Long-term success is defined as freedom from any electrocardiographic evidence of an AF episode >= 30 seconds' duration from the conclusion of the blanking period through the 6-month follow-up visit.
Key secondary outcomes Secondary Safety Endpoints
(1)The occurrence of Minor complications
(2)The occurrence of all non-serious adverse events and serious adverse events
(3)The occurrence of Major Complications will be assessed through the 12-month follow-up visit

Secondary Efficacy Endpoints
(1)The rate of long-term success through 12-month follow-up. (Freedom from any electrocardiographic evidence of an AF episode >= 30 seconds' duration from the conclusion of the blanking period through the 12-month follow-up visit.)
(2)QOL (SF-36)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Study Design: This is a nonrandomized, non-blinded, prospective pilot study. Thirty subjects with symptomatic paroxysmal or persistent AF will be enrolled. All subjects will receive pulmonary vein (PV) ablation at the PV antrum with the NTA-2 until the PV potential along the antrum is eliminated or dissociated. The ablation is executed under hospitalization. After the ablation procedure, there will be an eight-week blanking period to allow time for PV lesion healing. During the blanking period, AAD therapy (excluding amiodarone) will be permitted, but Class I and Class III AADs will not be allowed after conclusion of the blanking period. However, when investigator is unavoidable on treatment for the persistent AF patient, necessary minimum use of Class I or Class III AADs is assumed to be acceptable, and the reason and the content of use (the name of drug, dosage, period and administration route) are described in the case report form.
Follow-up visits for safety and effectiveness assessments will occur at discharge, 1, 3, 6 and 12 months post-ablation. Thirty subjects will be enrolled, and a preliminary data analysis will be performed after all subjects have completed his/her 6-month assessment. Results from the preliminary analysis will be used to support the design of the pivotal study. Subjects will also be followed out to 12 months for a safety and effectiveness assessment.
Interventions/Control_2
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 Enrolled subjects must meet all of the following inclusion criteria:
(1)Subject is =20 and <75 years old.
(2)Subject has been diagnosed with symptomatic paroxysmal or persistent AF that meets all of the following criteria:
i)At least two AF (paroxysmal AF) or one AF (persistent AF) episodes in the 6 months preceding study enrollment have occurred, and at least one documented AF episode via ECG, event monitor, or Holter monitor in the six months preceding study enrollment has occurred, and
ii)Any paroxysmal AF episode must spontaneously terminate within seven days of onset, or
iii)Any persistent AF episode must spontaneously terminate within one year of onset.
(3)Subject has failed to respond to or is intolerant of at least one Class I, II, III or IV AAD.("Intolerant " is defined as having suffered a clinically significant adverse drug effect).
(4)Subject is able and willing to provide informed consent.
Key exclusion criteria left atrium >= 50 mm.
amiodarone within six months.
undergone previous LA ablation or surgical treatment for AF.
LVEF< 35%.
NYHA Class III or IV.
history of MI or unstable angina.
non-revascularized left main or >= 3-vessel coronary artery disease.
severe mitral valve regurgitation or stenosis and is not an appropriate candidate for valvular intervention.
left atrial thrombus.
left atrial appendage occlusion device.
severe obstructive carotid artery disease.
hypertrophic cardiomyopathy with severe left ventricular outflow tract obstructions.
severe pulmonary arterial hypertension.
artificial heart valve.
pacemaker and or ICD.
history of cerebrovascular disease.
severe aortic stenosis.
IVC filter.
DVT.
significant renal failure.
known history of a bleeding disorder.
unable to take warfarin.
abnormal thyroid function.
allergy to iodine or iodine type of contrast media.
active malignancy of any kind.
pregnant or lactating.
participated in another clinical research study within 3 months.
judged to be unsuitable for participation.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keishi Miwa
Organization Toray Industries, Inc.
Division name Medical Devices Clinical Research Dept.
Zip code
Address 8-1, Mihama 1-chome, Urayasu, Chiba 279-8555, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Toray Industries, Inc.
Division name Medical Devices Clinical Research Dept.
Zip code
Address
TEL
Homepage URL
Email

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 医療法人沖縄徳洲会葉山ハートセンター(神奈川県)、国家公務員共済組合連合会横須賀共済病院(神奈川県)、医療法人社団高邦会福岡山王病院(福岡県)

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 19 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
2010 Year 05 Month 10 Day
Date of IRB
Anticipated trial start date
2010 Year 06 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 10 Month 19 Day
Last modified on
2012 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004521

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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