UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037569 |
|---|---|
| Receipt number | 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 | 2024/10/14 20:24:27 |
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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 after a single catheter ablation procedure.
Key secondary outcomes
Freedom from atrial fibrillation, atrial flutter or atrial tachycardia after multiple catheter ablation procedures.
Freedom from persistent atrial fibrillation, persistent atrial flutter or persistent atrial tachycardia after a single catheter ablation procedure.
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
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
yoshi-taka.cvm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
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
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
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
https://www.ahajournals.org/doi/full/10.1161/CIRCEP.124.012829
Publication of results
Published
Result
URL related to results and publications
https://www.ahajournals.org/doi/full/10.1161/CIRCEP.124.012829
Number of participants that the trial has enrolled
206
Results
A total of 98 patients were assigned to the mapping-guided group and 102 to the PVI alone group. Freedom from AF/atrial tachycardia without antiarrhythmic drugs at 2-year follow-up was 66.8% and 75.2% in the mapping-guided ablation and the PVI alone groups, respectively (hazard ratio 1.26 [95%CI 0.76-2.10], p=0.37).
Results date posted
| 2024 | Year | 10 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 07 | Month | 25 | Day |
Baseline Characteristics
200 patients undergoing their first catheter ablation for persistent or longstanding persistent AF were enrolled.
The mean age was 66.4 years and 66.8 years in the mapping-guided and the PVI alone groups, respectively.
Male was 81.6% and 82.4% in the mapping-guided and the PVI alone groups, respectively.
Participant flow
Screening was performed on 397 patients, 206 of whom agreed to participate in this study.
After randomization, 4 patients were excluded.
Adverse events
Adverse events occurred in 3 patients and none in the mapping-guided ablation and the PVI alone groups, respectively (p=0.12).
Outcome measures
Freedom from AF/AT without antiarrhythmic drugs beyond a 3-month blanking period.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 26 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 01 | Day |
Last modified on
| 2024 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042807
