UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043393
Receipt number R000049545
Scientific Title Randomized cOntol Trial of catheter Ablation Targeting substrate detected by ExTRa mapping (ROTATE) Study
Date of disclosure of the study information 2021/06/01
Last modified on 2022/02/18 19:53:48

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Basic information

Public title

The Randomized Controlled Trial Evaluating Utility of Catheter Ablation Us ing ExTRa mapping for Atrial Fibrillation
(ROTATE srudy)

Acronym

ROTATE srudy

Scientific Title

Randomized cOntol Trial of catheter Ablation Targeting substrate detected by ExTRa mapping (ROTATE) Study

Scientific Title:Acronym

ROTATE srudy

Region

Japan


Condition

Condition

Atrial fibrillation

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluated the utility of ExTRa mapping-guided ablation for persistent atrial fibrillation in reducing recurrent tachyarrhythmias after procedure.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Atrial arrhythmia recurrence beyond 90 days after catheter ablation for atrial fibrillation

Key secondary outcomes

Atrial fibrillation termination rate
Atrial fibrillation-free survival, atrial tachycardia-free survival
Procedure detail (procedure time, ablation number, ablation region)
Adverse events
Atrial arrhythmia recurrence beyond 90 days after repeat procedures
The difference of results compared between the different ExTRa-guide ablation in combined data with CONTROL-AF study


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

YES

Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Atrial sites of high %NP (%NP >35% and LVZ <0.5mV for the first 20 pts., and %NP >35% for the next 20 pts) were ablated, and electrical car diversion was performed when sinus resta nd electrical cardiversion was performed when sin us restoration was not obtained in 15 minutes after injection of Nifekalant 0.3mg/kg

Interventions/Control_2

No additional ablation after pulmonary veins isolation

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

21 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

First time ablation procedure for persistent atri al fibrillation
Patients who can be followed for at least 1-year after procedure
Patients from who we get written informed consent

Key exclusion criteria

Patients whose atrial fibrillation was restored after only pulmonay veins isolation
Patients who received ablation procedure or MAZE procedure for for atrial fibrillation before enrollment

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Satoshi
Middle name
Last name Shizuta

Organization

Kyoto University Hospital

Division name

Department of Cardiovascular Medicine

Zip code

606-8507

Address

54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto

TEL

075-751-4254

Email

shizuta@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Tetsuma
Middle name
Last name Kawaji

Organization

Mitsubisi Kyoto Hospital

Division name

Department of Cardiology

Zip code

615-8087

Address

1 Katsura Gosho-cho, Nishikyo-ku, Kyoto

TEL

075-381-2111

Homepage URL


Email

kawaji@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University Hospital

Institute

Department

Personal name



Funding Source

Organization

Operation Cost Grant

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Mitsubishi Kyoto Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto University Graduate School of Medicine and Faculty of Medicine, Ethics Committee

Address

54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Kyoto, Kyoto, Ky oto

Tel

075-753-4680

Email

ethcom@kuhp.kyoto-u.ac.jp


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

三菱京都病院(京都)、京都大学医学部附属病院(京都)


Other administrative information

Date of disclosure of the study information

2021 Year 06 Month 01 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

Open public recruiting

Date of protocol fixation

2021 Year 06 Month 01 Day

Date of IRB

2021 Year 05 Month 10 Day

Anticipated trial start date

2021 Year 06 Month 01 Day

Last follow-up date

2021 Year 06 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

2021 Year 02 Month 20 Day

Last modified on

2022 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=R000049545


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name