UMIN-CTR Clinical Trial

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

Paroxysmal or persistent atrial fibrillation

Classification by specialty

Cardiology

Operative medicine

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Toray Industries, Inc.

Institute

Department

Personal name

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2010

Year

10

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2010

Year

10

Month

19

Day

Last modified on

2012

Year

04

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004521