UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032433 |
|---|---|
| Receipt number | R000036985 |
| Scientific Title | The Evaluation of Efficacy and Safety of Radiofrequency Ablation and Cryoballoon Ablation in Patients with Atrial Fibrillation and Left Ventricular Dysfunction, Randomized Singlecenter Clinical Trial |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2022/11/01 10:24:34 |
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Basic information
Public title
The Evaluation of Efficacy and Safety of Radiofrequency Ablation and Cryoballoon Ablation in Patients with Atrial Fibrillation and Left Ventricular Dysfunction, Randomized Singlecenter Clinical Trial
Acronym
RF and Cryo Ablation of AF in Patients with LV dysfunction
Scientific Title
The Evaluation of Efficacy and Safety of Radiofrequency Ablation and Cryoballoon Ablation in Patients with Atrial Fibrillation and Left Ventricular Dysfunction, Randomized Singlecenter Clinical Trial
Scientific Title:Acronym
RF and Cryo Ablation of AF in Patients with LV dysfunction
Region
| Japan |
Condition
Condition
Atrial Fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of RF ablation and cryoablation of AF in patients with LV dysfunction
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. recurrence rate of atrial tachyarrhythmia 1 year after ablation
2. composite of all-cause mortality or worsening of heart failure requiring unplanned hospitalization
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
cryoballoon ablation
Interventions/Control_2
RF 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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Atrial fibrillation
2. Reduced LV contraction
Key exclusion criteria
1. Prior history of catheter ablation and/or surgery for atrial fibrillation
2. Normal LV contraction
3. Left atrial dimension more than 55 mm
4. Common pulmonary vein
5. Pregnant
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Kengo |
| Middle name | |
| Last name | Kusano |
Organization
National Cerebral and Cardiovascular Center
Division name
Division of Arrhythmia and Electrophysiology, Department of Cardiovascular Medicine
Zip code
564-8565
Address
6-1, Kishibeshimmachi, Suita, Osaka
TEL
06-6170-1070
kusanokengo@gmail.com
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Miyamoto |
Organization
National Cerebral and Cardiovascular Center
Division name
Division of Arrhythmia and Electrophysiology, Department of Cardiovascular Medicine
Zip code
564-8565
Address
6-1, Kishibeshimmachi, Suita, Osaka
TEL
06-6170-1070
Homepage URL
koji3koji3@gmail.com
Sponsor or person
Institute
Division of Arrhythmia and Electrophysiology, Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Basic Research Program of National Cerebral and Cardiovascular Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, National Cerebral and Cardiovascular Center
Address
6-1, Kishibeshinmachi, Suita, Osaka
Tel
06-6170-1070
rec-office-ac@ncvc.go.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 30 | Day |
Last modified on
| 2022 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036985
