UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025280
Receipt number R000028957
Scientific Title Cryo AF Global Registry
Date of disclosure of the study information 2016/12/15
Last modified on 2023/12/20 09:06:10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Cryo AF Global Registry

Acronym

Cryo AF Global Registry

Scientific Title

Cryo AF Global Registry

Scientific Title:Acronym

Cryo AF Global Registry

Region

Japan Asia(except Japan) South America
Europe


Condition

Condition

Drug refractory and reoccurrence symptomatic paroxysmal and persistent atrial fibrillation

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Study objectives are defined to estimate cryoballoon efficacy and safety, characterize the cryoballoon ablation, report on changes in subject QoL, and describe global standard of care for AF ablation patients receiving a CBA.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1.Twelve-month freedom from atrial fibrillation (AF) recurrence
2.Twelve-month freedom from AF / Atrial Flutter (AFL)/Atrial Tachycardia (AT) recurrence
3.Device or procedure related adverse events for cryoablation through 12 months


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Subject is over 18 years old of age
Planned procedure using commercially available Arctic Front Cardiac Cryoablation Catheter
Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) ot authorization per institution and geographical requirements

Key exclusion criteria

Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager.
Subject with exclusion criteria required by local law

Target sample size

4500


Research contact person

Name of lead principal investigator

1st name Lauren
Middle name
Last name Hemingway

Organization

Medtronic, Inc.

Division name

AFS Clinical

Zip code

55112

Address

8200 Coral Sea St. NE, MS:MVS46 | Mounds View, MN, 55112

TEL

1-763-526-0668

Email

lauren.hemingway@medtronic.com


Public contact

Name of contact person

1st name Takashi
Middle name
Last name Hamajima

Organization

Medtronic Japan Co., Ltd.

Division name

Clinical and Medical Affairs OU Clinical Division 4

Zip code

108-0075

Address

1-2-70 Konan, Minato-ku,Tokyo, 108-0075, Japan

TEL

070-1356-0767

Homepage URL


Email

takashi.hamajima@medtronic.com


Sponsor or person

Institute

Medtronic Japan Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Medtronic Japan Co., Ltd.

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

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

Yoshida-Konoe-cho, Sakyo-ku, Kyoto

Tel

075-753-4680

Email

ethcom@kuhp.kyoto-u.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

NCT02752737

Org. issuing International ID_1

ClinicalTrials.gov

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2016 Year 12 Month 15 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

1254

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

2015 Year 12 Month 09 Day

Date of IRB

2017 Year 02 Month 16 Day

Anticipated trial start date

2017 Year 02 Month 17 Day

Last follow-up date

2023 Year 06 Month 30 Day

Date of closure to data entry

2023 Year 09 Month 06 Day

Date trial data considered complete

2023 Year 09 Month 06 Day

Date analysis concluded



Other

Other related information

NA


Management information

Registered date

2016 Year 12 Month 15 Day

Last modified on

2023 Year 12 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028957


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name