UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044871 |
|---|---|
| Receipt number | R000051114 |
| Scientific Title | A Multicenter, Randomized, Parallel-Group Study of the Efficacy and Safety of a Low Ablation Index Group versus a High Ablation Index Group during Extensive Encircling Pulmonary Vein Isolation for Atrial Fibrillation |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2025/03/11 21:01:57 |
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Basic information
Public title
Optimal Ablation Index for Atrial Fibrillation during Extensive Encircling Pulmonary Vein Isolation Study
Acronym
Optimal Ablation Index for Atrial Fibrillation during Extensive Encircling Pulmonary Vein Isolation Study (IDEAL-PVI study)
Scientific Title
A Multicenter, Randomized, Parallel-Group Study of the Efficacy and Safety of a Low Ablation Index Group versus a High Ablation Index Group during Extensive Encircling Pulmonary Vein Isolation for Atrial Fibrillation
Scientific Title:Acronym
A Multicenter, Randomized, Parallel-Group Study of the Efficacy and Safety of a Low Ablation Index Group versus a High Ablation Index Group during Extensive Encircling Pulmonary Vein Isolation for Atrial Fibrillation (IDEAL-PVI study)
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will compare the acute effects of pulmonary vein isolation and the occurence of complications by dividing patients into two groups: a low group and a high group according to the target value of the Ablation Index during pulmonary vein isolation for atrial fibrillation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acute effects of extended encircling pulmonary vein isolation by high Ablation Index (presence of first-pass pulmonary vein isolation, presence of reconduction after waiting, presence of dormant conduction by ATP administration)
Key secondary outcomes
Assessment of safety of high Ablation Index (complications, procedure time, fluoroscopy time)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
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
<High Ablation Index Group>
The left pulmonary vein is ablated with an Ablation Index of 550-600 from the anterior wall of the left superior pulmonary vein, 600-650 from the anterior wall of the left carina, 400 from the anterior wall of the left inferior pulmonary vein to the posterior wall, 500-600 from the posterior wall of the left pulmonary vein, and 400-450 on the esophagus. (When the esophageal thermometer reaches 40 degree, the ablation is terminated even if the Ablation Index does not reach 400.) The right pulmonary vein is ablated with an Ablation Index 600-650 from the anterior wall to bottom of the right inferior pulmonary vein, 600 from the anterior wall to top of the right superior pulmonary vein, and 550-600 for the posterior wall of the right pulmonary vein.
Interventions/Control_2
<Low Ablation Index group>
The left pulmonary vein is ablated with an Ablation Index of 550 for the anterior wall of the carina, and 400 from the anterior wall of the left inferior pulmonary vein to the posterior wall. (When the esophageal thermometer reaches 40 degree, the ablation is terminated even if the Ablation Index does not reach 400.) The right pulmonary vein is ablated with an Ablation Index of 550 for the anterior wall and 400 from the bottom to the posterior wall.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients who will undergo the first ablation for atrial fibrillation.
(2) Females and males who are aged 20 years or older and 85 years or younger at the time of consent acquisition/enrollment date.
(3) The patient's written consent for participation in the study has been obtained.
Key exclusion criteria
(1) Patients with contraindications to anticoagulation.
(2) Patients with thrombus in the left atrium.
(2) Patients with intra-left atrial thrombus.
(3) Other patients who are judged by the investigator or sub-investigator to be unsuitable for this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Shizuta |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Cardiovascular Medicine
Zip code
606-8507
Address
54, Shogoin-Kawara cho, Sakyo-ku, Kyoto
TEL
075-751-4255
shizuta@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Shushi |
| Middle name | |
| Last name | Nishiwaki |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Cardiovascular Medicine
Zip code
606-8507
Address
54, Shogoin-Kawara cho, Sakyo-ku, Kyoto
TEL
075-751-4255
Homepage URL
s_nishiwaki@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Arrhythmia Donation
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
Kyoto University Certified Review Board
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-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
京都大学医学部附属病院（京都府）、三菱京都病院（京都府）、国立病院機構 京都医療センター（京都府）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | 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
0
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
| 2021 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 08 | 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
| 2021 | Year | 07 | Month | 15 | Day |
Last modified on
| 2025 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051114
