UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044940
Receipt number R000051333
Scientific Title Efficacy and Safety of Nepcell STM to Achieve Hemostasis after Removal of a 15-French Caliber Femoral Venous Sheath in Patients Undergoing Cryoballoon Ablation of Atrial Fibrillation.
Date of disclosure of the study information 2021/07/22
Last modified on 2022/01/20 12:13:09

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Basic information

Public title

Efficacy and Safety of Nepcell STM to Achieve Hemostasis after Removal of a 15-French Caliber Femoral Venous Sheath in Patients Undergoing Cryoballoon Ablation of Atrial Fibrillation.

Acronym

Efficacy and Safety of Nepcell STM to Achieve Hemostasis after Removal of a 15-French Caliber Femoral Venous Sheath in Patients Undergoing Cryoballoon Ablation of Atrial Fibrillation.

Scientific Title

Efficacy and Safety of Nepcell STM to Achieve Hemostasis after Removal of a 15-French Caliber Femoral Venous Sheath in Patients Undergoing Cryoballoon Ablation of Atrial Fibrillation.

Scientific Title:Acronym

Efficacy of Nepcell STM for Hemostasis

Region

Japan


Condition

Condition

atrial fibrillation

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This single center randomized clinical trial assessed the efficacy and safety of NC in patients undergoing CA for AF

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

time to hemostasis

Key secondary outcomes

internal hemorrhage, re-bleeding, duration of hospital stay, and 1-month vascular complications


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Nepcell group

Interventions/Control_2

conterol

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

90 years-old >

Gender

Male and Female

Key inclusion criteria

patients with non-valvular paroxysmal AF were admitted to our hospital to undergo cryoballoon ablation for AF.

Key exclusion criteria

HD

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Masao
Middle name
Last name Takemoto

Organization

Steel Memorial Yawata Hospital

Division name

Cardiovascular Center

Zip code

805-8508

Address

1-1-1 Harunomachi, Yahatahigashi-ku

TEL

093-672-3176

Email

matakemo@kc4.so-net.ne.jp


Public contact

Name of contact person

1st name Masao
Middle name
Last name Takemoto

Organization

Steel Memorial Yawata Hospital

Division name

Cardiovascular Center

Zip code

805-8508

Address

1-1-1 Harunomachi, Yahatahigashi-ku

TEL

093-672-3176

Homepage URL


Email

matakemo@kc4.so-net.ne.jp


Sponsor or person

Institute

Steel Memorial Yawata Hospital
Cardiovascular Center

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Steel Memorial Yawata Hospital

Address

1-1-1 Harunomachi, Yahatahigashi-ku

Tel

093-672-3176

Email

matakemo@kc4.so-net.ne.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



Other administrative information

Date of disclosure of the study information

2021 Year 07 Month 22 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.jstage.jst.go.jp/article/circrep/3/12/3_CR-21-0105/_pdf/-char/en

Number of participants that the trial has enrolled

62

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

2021 Year 07 Month 22 Day

Date of IRB

2019 Year 07 Month 09 Day

Anticipated trial start date

2021 Year 07 Month 22 Day

Last follow-up date

2021 Year 08 Month 22 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 07 Month 22 Day

Last modified on

2022 Year 01 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051333


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name