UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042543
Receipt number R000048342
Scientific Title Prospective trial of Radiofrequency Catheter Ablation of High Dominant Frequencies after Pulmonary Vein Isolation in Non-paroxysmal Atrial Fibrillation
Date of disclosure of the study information 2020/12/01
Last modified on 2022/12/02 13:39:15

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Basic information

Public title

Prospective trial of Radiofrequency Catheter Ablation of High Dominant Frequencies after Pulmonary Vein Isolation in Non-paroxysmal Atrial Fibrillation

Acronym

PAD-AF Trial

Scientific Title

Prospective trial of Radiofrequency Catheter Ablation of High Dominant Frequencies after Pulmonary Vein Isolation in Non-paroxysmal Atrial Fibrillation

Scientific Title:Acronym

PAD-AF Trial

Region

Japan


Condition

Condition

Non-paroxysmal Atrial Fibrillation

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aimed to evaluate the effect and safety of ablation at high-DF sites after pulmonary vein ablation (PVI) of non-paroxysmal AF.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The atrial fibrillation freedom off antiarrhythmic drugs after ablation at high-DF sites after PVI of non-paroxysmal AF during 12 months of follow-up

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is 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

ablation at high-DF sites after pulmonary vein ablation (PVI)

Interventions/Control_2

pulmonary vein ablation (PVI) alone

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

(1)non-valvular non-paroxysmal atrial fibrillation(continuous AF duration more than 6 months)
(2)Age between 20 and 80 years old at the time of obtaining consent
(3)Those who have obtained written consent of their own free will with a full understanding of the research subject.

Key exclusion criteria

(1)other investigational study involvement
(2)Mitral stenosis
(3)artificial valve
(4)Patients with cardiovascular events (stroke, myocardial infarction, heart failure requiring hospitalization) or bleeding requiring hospitalization within one month before registration
(5)life expectancy within one year
(6)LA thrombus
(7)left atrial size>50 mm
(8)prior AF ablation
(9)Patients who cannot continue taking anticoagulants
(10)pregnancy
(11)thyroid disease
(12)tumors
(13)LVEF<50%
(14)continuous AF duration more than 7 years
(15)HCM,DCM
(16)renal function<eGFR50ml/m/1.73m2dl

Target sample size

440


Research contact person

Name of lead principal investigator

1st name Koji
Middle name
Last name Kumagai

Organization

Tohoku Medical and Pharmaceutical University

Division name

Department of Cardiovascular Medicine

Zip code

983-8512

Address

1-12-1 Fukumuro Miyaginoku Sendaisi

TEL

022-259-1221

Email

kumagai4917@tohoku-mpu.ac.jp


Public contact

Name of contact person

1st name Koji
Middle name
Last name Kumagai

Organization

Tohoku Medical and Pharmaceutical University

Division name

Department of Cardiovascular Medicine

Zip code

022-259-1221

Address

1-12-1 Fukumuro Miyaginoku Sendaisi

TEL

022-259-1221

Homepage URL


Email

pad-af@hosp.touhoku-mpu.ac.jp


Sponsor or person

Institute

Tohoku Medical and Pharmaceutical University

Institute

Department

Personal name



Funding Source

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Independent Ethics Committee of Tohoku Medical and Pharmaceutical University Hospital

Address

1-12-1 Fukumuro Miyaginoku Sendaisi

Tel

022-259-1221

Email

tikenn@hosp.tohoku-mpu.ac.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

2020 Year 12 Month 01 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

Enrolling by invitation

Date of protocol fixation

2020 Year 08 Month 03 Day

Date of IRB

2020 Year 08 Month 03 Day

Anticipated trial start date

2020 Year 09 Month 02 Day

Last follow-up date

2026 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 11 Month 25 Day

Last modified on

2022 Year 12 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048342


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name