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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041752
Receipt No. 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 2020/09/18

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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
Institute Department of Cardiology, Sakakibara heart institute
Institute
Department

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 (1) tnagase@shi.heart.or.jp (2) hij-p@shi.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 日本心臓血圧研究振興会附属 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 Open public recruiting
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
2022 Year 04 Month 30 Day
Date of closure to data entry
2022 Year 07 Month 30 Day
Date trial data considered complete
2022 Year 07 Month 30 Day
Date analysis concluded
2022 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2020 Year 09 Month 10 Day
Last modified on
2020 Year 09 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047253

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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