UMIN-CTR Clinical Trial

Basic information
Public title	HotBalloon Pulmonary Vein isolation Registry Study - HARVEST Study -
Acronym	HotBalloon Registry Study - HARVEST Study -
Scientific Title	HotBalloon Pulmonary Vein isolation Registry Study - HARVEST Study -
Scientific Title:Acronym	HotBalloon Registry Study - HARVEST Study -
Region	Japan

Condition
Condition	atrial fibrillation
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate effectiveness and safety of SATAKE･HotBalloon ablation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Twelve-month freedom from atrial fibrillation (AF) recurrence
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	1. Subject is over 20 years old of age 2. Planned catheter-ablation of atrial fibrillation using SATAKE･HotBalloon Catheter
Key exclusion criteria	1. Subjects within life expectancy one year 2. Subjects who are judged inappropriate for the study by the physician
Target sample size	600

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazutaka Aonuma
Organization	University of Tsukuba Hospital
Division name	Cardiology
Zip code
Address	1-1-1 Tennoudai, Tsukuba, Ibaraki, 305-8575, Japan
TEL	029-853-3143
Email	hotballoon-society@umin.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yuki Nishiura
Organization	Mebix, Inc.
Division name	Development Div.
Zip code
Address	1-11-44 Akasaka, Minato-ku, Tokyo, 107-0052, Japan
TEL	03-4362-4504
Homepage URL
Email	harvest@mebix.co.jp

Sponsor
Institute	Japan Society of Hot Balloon Catheter
Institute
Department

Funding Source
Organization	TORAY Industries, Inc.
Organization
Division
Category of Funding Organization	Profit organization
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	2017 Year 10 Month 16 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	2017 Year 10 Month 10 Day
Date of IRB	2017 Year 11 Month 22 Day
Anticipated trial start date	2017 Year 11 Month 22 Day
Last follow-up date	2019 Year 06 Month 30 Day
Date of closure to data entry	2019 Year 07 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	NA

Management information
Registered date	2017 Year 10 Month 16 Day
Last modified on	2022 Year 01 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033785