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 | 2025/04/15 10:36:58 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
No longer recruiting
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
| 2025 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048342
