UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037033