UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018901
Receipt number R000021873
Scientific Title The safety and efficacy of radiofrequency ablation and cryoablation in patients with atrial fibrillation (AF) under anticoagulant therapy with apixaban
Date of disclosure of the study information 2015/09/03
Last modified on 2017/09/29 12:35:34

* 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

The safety and efficacy of radiofrequency ablation and cryoablation in patients with atrial fibrillation (AF) under anticoagulant therapy with apixaban

Acronym

The safety and efficacy of radiofrequency ablation and cryoablation in patients with atrial fibrillation (AF) under anticoagulant therapy with apixaban(J-HIT Study)

Scientific Title

The safety and efficacy of radiofrequency ablation and cryoablation in patients with atrial fibrillation (AF) under anticoagulant therapy with apixaban

Scientific Title:Acronym

The safety and efficacy of radiofrequency ablation and cryoablation in patients with atrial fibrillation (AF) under anticoagulant therapy with apixaban(J-HIT Study)

Region

Japan


Condition

Condition

atrial fibrillation

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparing radiofrequency ablation and cryoablation in patients with AF taking apixaban, and demonstrate the safety and efficacy of both therapies.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Composite of major bleedings and thromboembolism during perioperative period and within 4 weeks after the surgery.

Key secondary outcomes

Recurrence of AF during the follow-up period (because the presence or absence of recurrence may be associated with the development of embolic events), non-major bleeding, pericardial effusions not requiring drainage.


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


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

Apixaban_radiofrequency ablation

Interventions/Control_2

Apixaban_cryoablation

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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Patients who are indicated for catheter ablation for drug-resistant non-valvular paroxysmal AF in the Japanese Heart Rhythm Society Guidelines
2)Patients who undergo the first catheter ablation while taking apixaban
3)Patients of age between 20 and 85 years
4)Patients for whom consent for participation in this study have been obtained in writing

Key exclusion criteria

Patients with a history of hypersensitivity to the components of apixaban.
Patients with clinically significant bleeding symptoms.
Patients with blood clotting defect and liver disease at clinically significant bleeding risk.

Target sample size

260


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenzo Hirao

Organization

Tokyo Medical and Dental University

Division name

Heart Rhythm Center

Zip code


Address

1-5-45, Yushima, Bunkyo-ku, Tokyo

TEL

03-5803-5231

Email

0160.cvm@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Atsuhiko Yagishita

Organization

Tokyo Medical and Dental University

Division name

Department of Advanced technology in medicine

Zip code


Address

1-5-45, Yushima, Bunkyo-ku, Tokyo

TEL

03-5803-5231

Homepage URL


Email

atsuhikoyagishita.cvm@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Bristol-Myers Squibb

Organization

Division

Category of Funding Organization

Profit organization

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

さいたま赤十字病院(埼玉県)、土浦協同病院(茨城県)、横須賀共済病院(神奈川県)、武蔵野赤十字病院(東京都)


Other administrative information

Date of disclosure of the study information

2015 Year 09 Month 03 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

No longer recruiting

Date of protocol fixation

2015 Year 06 Month 30 Day

Date of IRB


Anticipated trial start date

2015 Year 09 Month 03 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

2015 Year 09 Month 03 Day

Last modified on

2017 Year 09 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021873


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name