UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041752
Receipt number R000047253
Scientific Title Impact of additional ablation for localized atrial fibrillation sources using a novel three-dimensional mapping system algorithm on atrial tachyarrhythmia recurrence in patients with persistent atrial fibrillation: a prospective randomized study
Date of disclosure of the study information 2020/09/16
Last modified on 2023/01/21 23:16:31

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Basic information

Public title

Impact of ablation for localized atrial fibrillation sources in patients with longstanding atrial fibrillation: a prospective randomized study

Acronym

Evaluation of ablation for localized atrial fibrillation sources

Scientific Title

Impact of additional ablation for localized atrial fibrillation sources using a novel three-dimensional mapping system algorithm on atrial tachyarrhythmia recurrence in patients with persistent atrial fibrillation: a prospective randomized study

Scientific Title:Acronym

Effect of ablation for localized atrial fibrillation sources identified by a novel three-dimensional mapping algorithm

Region

Japan


Condition

Condition

Atrial fibrillation

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate whether additional ablation to localized atrial fibrillation sources using a novel algorithm of three-dimensional mapping system (CARTOFINDER, Biosense Webster) plus conventional pulmonary vein isolation and ablation of non-pulmonary vein foci reduces atrial tachyarrhythmia recurrence in patients with persistent atrial fibrillation

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

1. Survival free rate from atrial tachyarrhythmia recurrence during 12 months follow-up after the index ablation

Key secondary outcomes

1. Procedural detail data including procedure time and complications
2. Relationship between left atrial low voltage area and atrial tachyarrhythmia recurrence rate after additional ablation to localized atrial fibrillation sources plus conventional pulmonary vein isolation and ablation of non-pulmonary vein foci
3. Change of left atrial function before and six months after the index ablation between two groups


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

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Patients with persistent atrial fibrillation undergoing pulmonary vein isolation and non-pulmonary vein foci ablation

Interventions/Control_2

Patients with persistent atrial fibrillation undergoing ablation for the localized atrial fibrillation sources identified by CARTOFINDER in addition to pulmonary vein isolation and non-pulmonary vein foci ablation

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

18 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Patients who have agreed to this study in the document
2) Patients aged 18 to 80
3) Patients with persistent atrial fibrillation with a duration of 1 week or more with drug resistance or wish for catheter ablation
4) Patients with a left atrium diameter of 55 mm or less
5) Patients with a left ventricular ejection fraction of over 45%

Key exclusion criteria

1) Patients with contraindications to anticoagulant therapy or unable to undergo catheter ablation due to cardiac thrombosis
2) Patients who have previously undergone catheter ablation for atrial fibrillation
3) Patients with a postprecedural follow-up period of less than six months
4) Patients with moderate or severe mitral or aortic valve valvular disease (regurgitation/stenosis)
5) Patients with hypertrophic cardiomyopathy
6) Patients with a history of myocardial infarction
7) Patients after transplantation of cardiac implantable electronic device
8) Patients for whom this study is not indicated because of other reasons (e.g., patients considered to be anatomically difficult to use CARTOFINDER)

Target sample size

160


Research contact person

Name of lead principal investigator

1st name Takahiko
Middle name
Last name Nagase

Organization

Sakakibara heart institute

Division name

Cardiology

Zip code

183-0003

Address

3-16-1 Asahi-cho, Fuchu-shi, Tokyo

TEL

(+81)42-314-3111

Email

tnagase@shi.heart.or.jp


Public contact

Name of contact person

1st name Takahiko
Middle name
Last name Nagase

Organization

Sakakibara heart institute

Division name

Cardiology

Zip code

183-0003

Address

3-16-1 Asahi-cho, Fuchu-shi, Tokyo

TEL

(+81)42-314-3111

Homepage URL


Email

tnagase@shi.heart.or.jp


Sponsor or person

Institute

Department of Cardiology, Sakakibara heart institute

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

1. Higashiyamato hospital
2. IMS Fujimi general hospital

Name of secondary funder(s)

None


IRB Contact (For public release)

Organization

Sakakibara heart institute

Address

3-16-1 Asahi-cho, Fuchu-shi, Tokyo 183-0003

Tel

(+81)42-314-3111

Email

sohta@mail.heart.or.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

1.公益財団法人 榊原記念財団 榊原記念病院(東京都) Sakakibara heart institute
2.社会医療法人財団大和会 東大和病院(東京都) Higashiyamato hospital
3.イムス富士見総合病院(埼玉県) IMS Fujimi general hospital


Other administrative information

Date of disclosure of the study information

2020 Year 09 Month 16 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

Terminated

Date of protocol fixation

2020 Year 09 Month 01 Day

Date of IRB

2020 Year 07 Month 17 Day

Anticipated trial start date

2020 Year 09 Month 16 Day

Last follow-up date

2024 Year 04 Month 30 Day

Date of closure to data entry

2024 Year 07 Month 30 Day

Date trial data considered complete

2024 Year 07 Month 30 Day

Date analysis concluded

2024 Year 09 Month 30 Day


Other

Other related information

Due to the restrictions on catheter ablation at facilities following repeated epidemics of new coronavirus infections and the fact that CARTOFINDER mapping itself requires about an additional hour, it takes time to register cases. Furthermore, it was confirmed that it takes time to accumulate cases by dividing the cases into two groups in a randomized prospective study. On top of that, considering the early return of the study results, it is considered better that the study design will be changed to a retrospective observational study comparing groups propesity score matching. This prospective randomized study was terminated because of those reasons.


Management information

Registered date

2020 Year 09 Month 10 Day

Last modified on

2023 Year 01 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047253


Research Plan
Registered date File name
2022/07/23 2022.3.17 研究実施計画書.pdf

Research case data specifications
Registered date File name
2022/03/13 2022.3 UMIN 症例データ仕様書.xls

Research case data
Registered date File name
2022/03/13 UMIN_CARTOFINDER研究データ_2022.3 .xls