UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032478 |
|---|---|
| Receipt number | R000037033 |
| Scientific Title | Right ventricular pacing during Cryoballoon ablation for atrial fibrillation |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2021/11/09 00:20:10 |
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Basic information
Public title
Right ventricular pacing during Cryoballoon ablation for atrial fibrillation
Acronym
RVP study
Scientific Title
Right ventricular pacing during Cryoballoon ablation for atrial fibrillation
Scientific Title:Acronym
RVP study
Region
| Japan |
Condition
Condition
Non-valvular atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Cryobaloon ablation for patients with atrial fibrillation is widely practiced worldwide including Japan as a safe and effective treatment. It has been reported that the nadir temperature of the cryoballoon is a predictor of myocardial injury during pulmonary vein isolation. And blood flow reduction in the left atrium by high frequency right ventricular pacing has been reported to contribute significantly reduction of the balloon temperature.
Right ventricular pacing is a procedure performed from an electrode catheter inserted in the right ventricle and has also been performed in daily cardiac electrophysiological examination, and its safety has been established.
We randomize the patients who underwent cryoballoon ablation in our institution to two groups whether or not high frequency right ventricular pacing is performed during cryoballoon freezing and observe prospectively the effect of myocardial injury and atrial fibrillation recurrence in the acute and chronic period.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Myocardial injury during catheter ablation
Recurrence of atrial fibrillation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are 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
Pulmonary vein isolation is performed normally as a cryoballoon.
Interventions/Control_2
High frequency right ventricular pacing is performed with an electrode catheter inserted from the femoral vein during cryoballoon freezing.
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 underwent cryoballoon ablation for atrial fibrillation at our hospital
2. Patients who is 20 years of age or older
3. Patietns who obtained written consent.
Key exclusion criteria
1. Patients who are suffering from cancer and have not received notification (at the time of consent acquisition)
2. Patients who have low left ventricular ejection fraction (less than 30%) or severe aortic valve stenosis
3. Patients who have coronary artery stenosis by preoperative evaluation
4. Patients who have been judged as the inappropriate subject of this research by the research director or assigned researcher
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuro Nishimura |
Organization
Japan Red Cross Yokohama City Bay Hospital
Division name
Heart Center
Zip code
Address
3-12-1 Shinyamashita Naka-ward Yokohama Kanagawa 231-0801, Japan
TEL
045-628-6100
takhighstepping326@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuro Nishimura |
Organization
Japan Red Cross Yokohama City Bay Hospital
Division name
Heart Center
Zip code
Address
3-12-1 Shinyamashita Naka-ward Yokohama Kanagawa 231-0801, Japan
TEL
045-628-6100
Homepage URL
takhighstepping326@yahoo.co.jp
Sponsor or person
Institute
Japan Red Cross Yokohama City Bay Hospital
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
Address
Tel
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 | 06 | 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
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 10 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 10 | Day |
Date analysis concluded
| 2019 | Year | 08 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 06 | Day |
Last modified on
| 2021 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037033
