UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045447
Receipt number R000051888
Scientific Title Retrospective study about the prognosis in patients with non-valvular atrial fibrillation who underwent a percutaneous left atrial appendage closure.
Date of disclosure of the study information 2021/09/10
Last modified on 2023/09/13 22:24:24

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Basic information

Public title

Retrospective study about the prognosis in patients with non-valvular atrial fibrillation who underwent a percutaneous left atrial appendage closure.

Acronym

Retrospective study about left atrial appendage closure device

Scientific Title

Retrospective study about the prognosis in patients with non-valvular atrial fibrillation who underwent a percutaneous left atrial appendage closure.

Scientific Title:Acronym

Retrospective study about left atrial appendage closure device

Region

Japan


Condition

Condition

Nonvalvular atrial fibrillation

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Patients with nonvalvular atrial fibrillation who underwent percutaneous left atrial appendage closure

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

All-cause death

Key secondary outcomes

cardiovascular death, ischemic stroke, major bleeding event


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

percutaneous left atrial appendage clusore

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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

patients with nonvalvular atrial fibrillation who have a high risk of stroke and systemic embolism, based on the CHADS2 or CHA2DS2-VASc scores and a high risk of bleeding with at least one following condition.

- Patients with a HAS-BLED score of 3 or higher
- Patients with a history of trauma associated with a fall that required treatment for multiple injuries
- Patients with a history of diffuse cerebral amyloid angiopathy
- Patients who require the concomitant use of two or more antiplatelet agents for an extended period of time (more than 1 year)
- Patients with a history of major bleeding that meets the BARC type 3 criteria

Key exclusion criteria

1. patients requiring long-term use of oral anticoagulants for reasons other than non-valvular atrial fibrillation (e.g., patients with implanted mechanical prosthetic valves, patients with hypercoagulable states, or patients with recurrent DVT)
2. patients with evidence of intracardiac (especially intra-atrial) thrombus.
3. patients with atrial septal defect or foramen ovale repair (surgery, device implantation, etc.), or patients with atrial septal defect or foramen ovale repair (surgery, device implantation, etc.).
Patients with a history of atrial septal defect or atrial septal suture closure.
4. patients with anatomical structures of the left ventricular ear that are not amenable to closure devices.
5. patients with contraindications to left ventricular closure (transesophageal echocardiography (TEE)) or patients with contraindications to left ventricular closure (e.g., difficulty in inserting transesophageal echocardiography (TEE) probe or catheter required for the procedure).
6. patients with contraindications to anticoagulation, aspirin, or thienopyridine.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Masato
Middle name
Last name Fukunaga

Organization

Kokura Memorial Hospital

Division name

Department of Cardiology

Zip code

802-8555

Address

3-2-1, Asano kokurakita, Kitakyushu Japan

TEL

0935112000

Email

masato_f0728@yahoo.co.jp


Public contact

Name of contact person

1st name Masato
Middle name
Last name Fukunaga

Organization

Kokura Memorial Hospital

Division name

Department of Cardiology

Zip code

802-8555

Address

3-2-1, Asano kokurakita, Kitakyushu Japan

TEL

093-511-2000

Homepage URL


Email

masato_f0728@yahoo.co.jp


Sponsor or person

Institute

Department of Cardiology, Kokura Memorial Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

the institutional review board of Kokura Memorial Hospital

Address

3-2-1, Asano kokurakita, Kitakyushu Japan

Tel

093-511-2000

Email

rinsyo@kokurakinen.or.jp


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

小倉記念病院


Other administrative information

Date of disclosure of the study information

2021 Year 09 Month 10 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

Open public recruiting

Date of protocol fixation

2021 Year 08 Month 18 Day

Date of IRB

2021 Year 09 Month 02 Day

Anticipated trial start date

2021 Year 09 Month 02 Day

Last follow-up date

2031 Year 09 Month 02 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 09 Month 10 Day

Last modified on

2023 Year 09 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051888


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name