UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046550
Receipt number R000053109
Scientific Title Clinical outcomes of CARTO FINDER and CFAE (ICL mode) ablation after pulmonary vein isolation for persistent atrial fibrillation
Date of disclosure of the study information 2022/01/05
Last modified on 2025/02/04 17:31:37

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Basic information

Public title

Clinical outcomes of CARTO FINDER and CFAE (ICL mode) ablation after pulmonary vein isolation for persistent atrial fibrillation

Acronym

Clinical outcomes of CARTO FINDER and CFAE (ICL mode) ablation after pulmonary vein isolation for persistent atrial fibrillation

Scientific Title

Clinical outcomes of CARTO FINDER and CFAE (ICL mode) ablation after pulmonary vein isolation for persistent atrial fibrillation

Scientific Title:Acronym

Clinical outcomes of CARTO FINDER and CFAE (ICL mode) ablation after pulmonary vein isolation for persistent atrial fibrillation

Region

Japan


Condition

Condition

persistent atrial fibrillation

Classification by specialty

Medicine in general Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Clinical outcomes of CARTO FINDER and CFAE (ICL mode) ablation after pulmonary vein isolation for persistent atrial fibrillation

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

2) Total number of PACs PAC short run AT(1,3,6,12 months after surgery)
3) Change in resting heart rate from baseline (1,3,6,12 months after surgery)
4) Amount of change from baseline in the following biochemical tests (3,6,12 months after surgery)
Triglyceride, LDL / HDL cholesterol, fatty acid 4 fraction, hemoglobin, hematocrit, cystatin C, renin, aldosterone, Brain natriuretic peptide, Atrial natriuretic peptide, NT-pro BNP
5) Amount of change from baseline in the following echocardiographic findings (3,12 months after surgery)
Left ventricular ejection fraction (LVEF), presence or absence of MR (none, mild, moderate, severe), tricuspid regurgitation pressure gradient (none, mild, moderate, severe), left ventricular end diastolic diameter, left ventricular end systole diameter, Left ventricle diameter

Key secondary outcomes

1) Total number of PACs PAC short run. AT(1,3,6,12 months after surgery)
2) Change in resting heart rate from baseline (1,3,6,12 months after surgery)
3) Amount of change from baseline in the following biochemical tests (3,6,12 months after surgery)
Triglyceride, LDL / HDL cholesterol, fatty acid 4 fraction, hemoglobin, hematocrit, cystatin C, renin, aldosterone, Brain natriuretic peptide, Atrial natriuretic peptide, NT-pro BNP
4) Amount of change from baseline in the following echocardiographic findings (3,12 months after surgery)
Left ventricular ejection fraction (LVEF), presence or absence of MR (none, mild, moderate, severe), tricuspid regurgitation pressure gradient (none, mild, moderate, severe), left ventricular end diastolic diameter, left ventricular end systole diameter, Left ventricle diameter


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

CARTOFINDER+CFAE(ICL mode)ablation

Interventions/Control_2

Pulmonary vein isolation

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

85 years-old >

Gender

Male and Female

Key inclusion criteria

1 Patients with persistent atrial fibrillation during hospital visits who relapsed after 1st ablation
2 Patients who underwent only expanded pulmonary vein isolation in 1st ablation
3 Patients who are indicated for catheter ablation. (Japanese Circulation Society Arrhythmia Drug Treatment Guidelines (Revised 2018)
4 Patients whose age at the time of obtaining consent is 20 to 85 years old
5 Patients who can consent by themselves

Key exclusion criteria

1 Patients who have difficulty in restoring sinus rhythm by cardioversion
2 Patients who do not agree to be the target of this case
3 Patients with persistent atrial fibrillation
4 Other patients who are not qualified by the attending physician

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Morio
Middle name
Last name Ono

Organization

Showa University Northern Yokohama Hospital

Division name

Cardiology

Zip code

224-8503

Address

35-1,chigasakichuuou, yokohamashitudukiku,kanagawa

TEL

(+81)45-949-7000

Email

morio.ono@gmail.com


Public contact

Name of contact person

1st name Morio
Middle name
Last name Ono

Organization

Showa University Northern Yokohama Hospital

Division name

Cardiology

Zip code

224-8503

Address

35-1,chigasakichuuou, yokohamashitudukiku,kanagawa

TEL

(+81)45-949-7000

Homepage URL


Email

morio.ono@gmail.com


Sponsor or person

Institute

Showa University Northern Yokohama Hospital

Institute

Department

Personal name



Funding Source

Organization

nothing

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

Department of Cardiology University Northern Yokohama Hospital

Address

35-1,chigasakichuuou, yokohamashitudukiku,kanagawa

Tel

(+81)45-949-7000

Email

morio.ono@gmail.com


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

2022 Year 01 Month 05 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

2022 Year 01 Month 05 Day

Date of IRB

2022 Year 01 Month 05 Day

Anticipated trial start date

2022 Year 01 Month 05 Day

Last follow-up date

2025 Year 01 Month 05 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2022 Year 01 Month 05 Day

Last modified on

2025 Year 02 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053109