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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037569
Receipt No. R000042807
Scientific Title Mapping-Guided Ablation for Persistent Atrial Fibrillation [MAP-AF] Trial
Date of disclosure of the study information 2019/12/01
Last modified on 2019/09/23

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Basic information
Public title Mapping-Guided Ablation for Persistent Atrial Fibrillation [MAP-AF] Trial
Acronym MAP-AF trial
Scientific Title Mapping-Guided Ablation for Persistent Atrial Fibrillation [MAP-AF] Trial
Scientific Title:Acronym MAP-AF trial
Region
Japan

Condition
Condition atrial fibrillation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate efficacy of mapping-guided ablation in combination with pulmonary vein isolation in patients with persistent atrial fibrillation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Freedom from atrial fibrillation, atrial flutter or atrial tachycardia during 1-year after a single catheter ablation procedure.
Key secondary outcomes Freedom from atrial fibrillation, atrial flutter or atrial tachycardia during 1-year after multiple catheter ablation procedures.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 In addition to pulmonary vein isolation, mapping-guided ablation is performed.
Interventions/Control_2 Pulmonary vein isolation is performed.
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
90 years-old >
Gender Male and Female
Key inclusion criteria 1) Symptomatic persistent or longstanding persistent atrial fibrillation.
2) Documentation of AF 3-month before the enrollment of the study.
3) Documentation of sinus rhythm within 3-year before the enrollment of the study.
4) Refractory or intolerent to antiarrhythmic drugs.
Key exclusion criteria 1) Sinus rhythm from 3-month before the enrollment of the study to the beginning of the ablation procedure.
2) Prior catheter ablation for atrial fibrillation or uncommon atrial flutter.
3) Prior surgical Maze procedure.
4) Patients in whom cardiac implantable electronic devices were implanted.
5) Patients who were taking aimodarone within 1-year from the enrollment of the study.
6) Untreated thyroild dysfunction.
7) End-stage renal disease (eGFR<15 or requirement of hemodialysis).
Target sample size 206

Research contact person
Name of lead principal investigator
1st name Yoshihide
Middle name
Last name Takahashi
Organization Tokyo Medical and Dental University
Division name Department of Advanced Arrhythmia Research
Zip code 113-8510
Address Yushima 1-5-45, Bunkyo-ku, Tokyo
TEL 0358035231
Email yoshi-taka.cvm@tmd.ac.jp

Public contact
Name of contact person
1st name Yoshihide
Middle name
Last name Takahashi
Organization Tokyo Medical and Dental Unive
Division name Department of Advanced Research
Zip code 113-8510
Address Yushima 1-5-45, Bunkyo-ku, Tokyo
TEL 0358035231
Homepage URL
Email yoshi-taka.cvm@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization None
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 Tokyo Medical and Dental Unive
Address Yushima 1-5-45, Bunkyo-ku, Tokyo
Tel 0358035231
Email yoshi-taka.cvm@tmd.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 神戸市立医療センター中央市民病院(兵庫県)、小倉記念病院(福岡県)、さいたま赤十字病院(埼玉県)、東京医療センター(東京都)、豊橋ハートセンター(愛知県)、弘前大学医学部付属病院(青森県)

Other administrative information
Date of disclosure of the study information
2019 Year 12 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 Preinitiation
Date of protocol fixation
2019 Year 10 Month 01 Day
Date of IRB
2019 Year 09 Month 20 Day
Anticipated trial start date
2019 Year 12 Month 01 Day
Last follow-up date
2021 Year 07 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
2019 Year 08 Month 01 Day
Last modified on
2019 Year 09 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042807

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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