UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006127 |
|---|---|
| Receipt number | R000007236 |
| Scientific Title | The Multicenter Prospective Randomized Controlled Trial Evaluating Efficacy of Pharmacological Approaches to Improve Long-Term Outcome of Catheter Ablation for Atrial Fibrillation: Kansai Plus Atrial Fibrillation (KPAF) trial |
| Date of disclosure of the study information | 2011/08/08 |
| Last modified on | 2015/05/03 13:25:50 |
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Basic information
Public title
The Multicenter Prospective Randomized Controlled Trial Evaluating Efficacy of Pharmacological Approaches to Improve Long-Term Outcome of Catheter Ablation for Atrial Fibrillation: Kansai Plus Atrial Fibrillation (KPAF) trial
Acronym
KPAF trial
Scientific Title
The Multicenter Prospective Randomized Controlled Trial Evaluating Efficacy of Pharmacological Approaches to Improve Long-Term Outcome of Catheter Ablation for Atrial Fibrillation: Kansai Plus Atrial Fibrillation (KPAF) trial
Scientific Title:Acronym
KPAF trial
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the efficacy of two different pharmacological approaches to improve long-term outcome of catheter ablation for atrial fibrillation. The pharmacological approaches consist of additional radiofrequency energy applications to eliminate dormant left atrium (LA) - pulmonary vein (PV) reconduction induced by adenosine triphosphate (ATP) injection during the procedure, and short-term (90 days) use of anti-arrhythmic drugs following successful catheter ablation for atrial fibrillation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Event-free rate from atrial tachyarrhythmia after catheter ablation for atrial fibrillation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
UNmasking Dormant Electrical Reconduction by Adenosine TriPhosphate (UNDER-ATP) trial
Patients are randomized in a 1:1 ratio to control or ATP groups.
Following successful pulmonary vein (PV) isolation, ATP (0.4mg/body weight-kg) is rapidly injected to induce the dormant left atrium (LA) - PV conduction. If dormant LA-PV conduction is induced, additional radiofrequency energy is delivered to the conduction gap until loss of ATP-induced reconduction is recognized.
Interventions/Control_2
Efficacy of Antiarrhythmic drugs Short-Term use after catheter ablation for Atrial Fibrillation (EAST-AF) trial
Patients are randomized in a 1:1 ratio to control or antiarrhythmic drug (AAD) groups immediately after successful catheter ablation for atrial fibrillation.
Vaughan Williams class I or III AAD is used for 90 days after the procedure in the AAD group.
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
| 21 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing first catheter ablation for paroxysmal or persistent atrial fibrillation, who are 21-79 years old, able to be followed for one year in an out-patient clinic and willing to sign the consent form for participation, are eligible for the study.
Key exclusion criteria
1) Patients who are intolerant for ATP or antiarrhythmic drugs (Vaughan Williams class I or III), including those in acute phase of intracranial bleeding and those with severe bronchial asthma, severe vasospastic angina, substantial bradycardia, a history of allergy for ATP or antiarrhythmic drugs or a history of severe adverse effect of ATP or antiarrhythmic drugs.
2) Patients equal or younger than 20 years and those equal or older than 80years
3) Patients who are unable to be followed in an out-patient clinic for one year
4) Patients with renal insufficiency (serum creatinine >=2.0mg/dl or hemodialysis)
5) Patients with NYHA class IV heart failure
6) Left ventricular ejection fraction < 40%
7) Left atrial diameter > 55mm
8) Very long-lasting (>=5years) persistent atrial fibrillation
9) Patients ineligible for optimal anticoagulant therapy
10) Patients with a history of myocardial infarction within the past 6 months
11) Patients with a history of open heart surgery
12) Patients with a planned open heart surgery
13) Patients with severe valve heart disease
14) Patients unwilling to sign the consent form for participation
15) When the attending physician are unwilling to enroll the patient in the study
16) When the attending physician consider inappropriate to enroll the patient in the study
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Shizuta |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
54 Kawahara-cho, Shougoin, Sakyo-ku, Kyoto, 606-8507, Japan
TEL
075-751-4255
shizuta@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Shizuta |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
54 Kawahara-cho, Shougoin, Sakyo-ku, Kyoto, 606-8507, Japan
TEL
075-751-4255
Homepage URL
shizuta@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Research Institute for Production Development
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 08 | Month | 08 | 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
| 2011 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a 2x2 factorial randomized controlled trial, which consists of UNDER-ATP and EAST-AF trials.
Management information
Registered date
| 2011 | Year | 08 | Month | 08 | Day |
Last modified on
| 2015 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007236
