UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000031322 |
|---|---|
| Receipt number | R000035436 |
| Scientific Title | Clinical trial to estimate safety and efficacy of radiation ablation therapy using CyberHeart System for atrial fibrillation of cancer patient. |
| Date of disclosure of the study information | 2018/02/16 |
| Last modified on | 2019/09/05 10:54:04 |
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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
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
koinaba@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital, Japan.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035436
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