UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019449
Receipt number R000022454
Scientific Title Effect of Extensive Ablation on Recurrence in Patients with Persistent Atrial Fibrillation Treated with Pulmonary Vein Isolation -a Multicenter, Randomized, Open-Label, Non-Inferiority Study-
Date of disclosure of the study information 2015/10/22
Last modified on 2023/10/15 18:08:58

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Basic information

Public title

Effect of Extensive Ablation on Recurrence in Patients with Persistent Atrial Fibrillation Treated with Pulmonary Vein Isolation -a Multicenter, Randomized, Open-Label, Non-Inferiority Study-

Acronym

Effect of Extensive Ablation on Recurrence in Patients with Persistent Atrial Fibrillation Treated with Pulmonary Vein Isolation (EARNEST-PVI)

Scientific Title

Effect of Extensive Ablation on Recurrence in Patients with Persistent Atrial Fibrillation Treated with Pulmonary Vein Isolation -a Multicenter, Randomized, Open-Label, Non-Inferiority Study-

Scientific Title:Acronym

Effect of Extensive Ablation on Recurrence in Patients with Persistent Atrial Fibrillation Treated with Pulmonary Vein Isolation (EARNEST-PVI)

Region

Japan


Condition

Condition

Persistent atrial fibrillation

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine non-inferiority of pulmonary vein isolation for persistent atrial fibrillation (AF) to extensive ablation; and to reveal the effect of the presence or the origin of AF trigger on outcomes of catheter ablation

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

the one-year recurrence rate of atrial fibrillation following the first session of catheter ablation

Key secondary outcomes

cardiovascular events:
death (and/or cause of death), symptomatic cerebral infarction, the recurrence rate of atrial fibrillation following multiple ablations; complications associated with catheter ablation; Total energy; procedure time; and QOL score assessed by SF-36


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Group A: Pulmonary vein isolation

Interventions/Control_2

Group B: Pulmonary vein isolation with extensive ablations

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

Patients undergoing a first-time ablation procedure for persistent atrial fibrillation

Key exclusion criteria

Patients with sustained atrial fibrillation episode 5 years or greater;
Patients with left atrial size 50 mm or larger or left atrial volume 200ml or larger;
Patients with valvular atrial fibrillation and a history of cardiac surgery;
Patients age is < 20 years or 80 years or greater;
Dialysis patients;
Patients with heart failure (LVEF < 30% or NYHA class III or IV);
Patients taking antiarrhythmic drugs before procedure; or
Patients considered unsuitable for this study

Target sample size

512


Research contact person

Name of lead principal investigator

1st name Yasushi
Middle name
Last name Sakata

Organization

Osaka University Graduate School of Medicine

Division name

Department of Cardiovascular Medicine

Zip code

565-0871

Address

2-2 Yamadaoka, Suita, Osaka, Japan

TEL

06-6879-3631

Email

yasushisk@cardiology.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name Shungo
Middle name
Last name Hikoso

Organization

Osaka University Graduate School of Medicine

Division name

Department of Cardiovascular Medicine

Zip code

565-0871

Address

2-2 Yamadaoka, Suita, Osaka, Japan

TEL

06-6879-3631

Homepage URL


Email

hikoso@cardiology.med.osaka-u.ac.jp


Sponsor or person

Institute

Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine

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

Osaka university hospital

Address

2-15 Yamadaoka, Suita, Osaka, Japan

Tel

06-6210-8289

Email

rinri@hp-crc.med.osaka-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

大阪大学医学部附属病院 循環器内科(大阪府)、大阪警察病院(大阪府)、大阪府立急性期・総合医療センター(大阪府)、大阪労災病院(大阪府)、関西労災病院(兵庫県)、特定医療法人渡辺医学会桜橋渡辺病院(大阪府)、八尾市立病院(大阪府)、JCHO大阪病院(大阪府)


Other administrative information

Date of disclosure of the study information

2015 Year 10 Month 22 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

2015 Year 10 Month 16 Day

Date of IRB

2015 Year 10 Month 14 Day

Anticipated trial start date

2016 Year 03 Month 02 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 10 Month 22 Day

Last modified on

2023 Year 10 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022454


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name