UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047638 |
|---|---|
| Receipt number | R000054321 |
| Scientific Title | Adjunctive posterior wall isolation for treatment of persistent and longstanding persistent atrial fibrillation Trial (CORNERSTONE AF) |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2023/12/31 21:49:07 |
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Basic information
Public title
Adjunctive posterior wall isolation for treatment of persistent and longstanding persistent atrial fibrillation Trial (CORNERSTONE AF)
Acronym
CORNERSTONE AF
Scientific Title
Adjunctive posterior wall isolation for treatment of persistent and longstanding persistent atrial fibrillation Trial (CORNERSTONE AF)
Scientific Title:Acronym
CORNERSTONE AF
Region
| Japan |
Condition
Condition
Persistent atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of the empirical left atrial posterior wall isolation added to pulmonary vein isolation in catheter ablation for persistent atrial fibrillation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Freedom from any documented atrial arrhythmias during 18 months follow-up after a single ablation procedure with or without the use of antiarrhythmic medications
Key secondary outcomes
Freedom from any documented atrial fibrillation (AF) episodes
Freedom from any documented atrial tachycardia/flutter episodes
AF burden between study arms
Freedom from any documented symptomatic atrial arrhythmias
Procedural duration and fluoroscopy time
Posterior wall isolation success rate
Freedom from repeat ablation procedure
Freedom from direct current cardioversions for recurrent arrhythmias
Peri-procedural complications
Assessment of upper gastrointestinal symptom severity index during peri-procedural period
The impact of the use of cryoballoon
Wristwatch-Based Photoplethysmography for arrhythmia detection
The impact of area of isolated posterior wall on outcomes
The impact of the presence of left atrial low voltage area on outcomes
Type of ablation catheters and 3-dimensional mapping systems
Pulmonary vein isolation durability during second procedure
Freedom from any documented atrial arrhythmias after repeat ablation procedure with or without the use of antiarrhythmic medications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Pulmonary vein isolation
Interventions/Control_2
Empirical left atrial posterior wall isolation added to pulmonary vein isolation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with initial ablation for persistent atrial fibrillation (lasting for >7 days and <3 years)
At least 1 episode of persistent AF have been documented within last 1 y of enrollment
Key exclusion criteria
Patients who underwent prior cardiac surgery
Patients with left atrial size >55 mm
Patients with heart failure (NYHA class 4)
Patients with AF secondary to a reversible cause
Patients with contraindications to systemic anticoagulation
Patients who are pregnant
Patients receiving hemodialysis
Patients who are not considered to be suitable candidates by the attending physician
Target sample size
516
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Sasano |
Organization
Tokyo Medical and Dental University
Division name
Department of cardiovascular medicine
Zip code
113-8519
Address
1-5-45, Bunkyo-ku, Tokyo
TEL
03-5803-5205
sasano.cvm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Miyazaki |
Organization
Tokyo Medical and Dental University
Division name
Department of cardiovascular medicine
Zip code
113-8519
Address
1-5-45, Bunkyo-ku, Tokyo
TEL
03-5803-5231
Homepage URL
mshicvm@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 University IRB
Address
1-5-45, Bunkyo-ku, Tokyo
Tel
03-5803-5096
syomu1.adm@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
AOI国際病院(神奈川県)、青梅市立総合病院(東京都)、柏市立柏病院(千葉県)、亀田総合病院(千葉県)、さいたま赤十字病院(埼玉県)、榊原記念病院(東京都)、自治医科大学附属さいたま医療センター(埼玉県)、草加市立病院(埼玉県)、総合病院土浦協同病院(茨城県)、東京医科歯科大学(東京都)、東京都保健医療公社豊島病院(東京都)、東京山手メディカルセンター(東京都)、平塚共済病院(神奈川県)、武蔵野赤十字病院(東京都)、横須賀共済病院(神奈川県)、横浜市立みなと赤十字病院(神奈川県)、横浜南共済病院(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2022 | Year | 05 | Month | 01 | Day |
Last modified on
| 2023 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054321
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| Registered date | File name |
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