UMIN-CTR Clinical Trial

Basic information
Public title	Clinical trial to estimate safety and efficacy of radiation ablation therapy using CyberHeart System for atrial fibrillation of cancer patient.
Acronym	Clinical trial to estimate safety and efficacy of radiation ablation therapy for atrial fibrillation of cancer patient.
Scientific Title	Clinical trial to estimate safety and efficacy of radiation ablation therapy using CyberHeart System for atrial fibrillation of cancer patient.
Scientific Title:Acronym	Clinical trial to estimate safety and efficacy of radiation ablation therapy for atrial fibrillation of cancer patient.
Region	Japan

Condition
Condition	Atrial fibrillation of cancer patient
Classification by specialty	Cardiology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To estimate the safety and efficacy of radiation ablation therapy using CyberHeart system for atrial fibrillation which is not controlled by medication or catheter ablation or is not eligible to these therapies.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence and severity of the adverse events by radiation ablation therapy.
Key secondary outcomes	Control rate of atrial fibrillation in 6 months

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Radiation ablation therepy
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	84 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Patient with cancer. 2) Patient who will not have cure treatment for cancer. 3) Atrial fibrillation diagnosed by EKG or Holter EKG. 4) Patient with atrial fibrillation which is not controlled by medication. 5) Two cardiologist judge catheter ablation is not applied. 6) Patient does not have medical history of surgey for atrial fibrillation such as Mase surgery. 7) Age: 20-84. 8) Writtend informed consent. 9) Serum creatinine value under 1.3 mg/dL. 10) Patient does not have second and third degree auriculoventricular block. 11) Patient does not have uncontrolled hyperthyroidism. 12) The size of left atrium estimated by transthoracic cardiac ultrasound is less than or equal to 55 mm. 13) The ejection fraction of left venricule estimated by transthoracic cardiac ultrasound is more than or equal to 35%.
Key exclusion criteria	1) Acute myocardial infarction in 8 weeks before enrollment. 2) Other clinical trial entry 3) Pregnancy
Target sample size	3

Research contact person
Name of lead principal investigator	1st name Middle name Last name Jun Itami
Organization	National Cancer Center Hospital, Japan.
Division name	Department of Radiation Oncology.
Zip code
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan.
TEL	03-3542-2511
Email	jitami@ncc.go.jp

Public contact
Name of contact person	1st name Middle name Last name Koji Inaba
Organization	National Cancer Center Hospital, Japan.
Division name	Department of Radiation Oncology.
Zip code
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan.
TEL	03-3542-2511
Homepage URL
Email	koinaba@ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital, Japan.
Institute
Department

Funding Source
Organization	CyberHeart Inc. Kay's Japan, 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	2018 Year 02 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 01 Month 28 Day
Date of IRB	2017 Year 02 Month 01 Day
Anticipated trial start date	2017 Year 02 Month 16 Day
Last follow-up date	2018 Year 03 Month 06 Day
Date of closure to data entry	2018 Year 03 Month 06 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 02 Month 15 Day
Last modified on	2019 Year 09 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035436