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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042543
Receipt No. 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 2020/11/25

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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
Institute Tohoku Medical and Pharmaceutical University
Institute
Department

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
2022 Year 12 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
2020 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.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


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