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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032478
Receipt No. 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 2018/05/06

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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
Email 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
Email takhighstepping326@yahoo.co.jp

Sponsor
Institute Japan Red Cross Yokohama City Bay Hospital
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2018 Year 05 Month 06 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 06 Day
Last modified on
2018 Year 05 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037033

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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