UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044793 |
|---|---|
| Receipt number | R000051156 |
| Scientific Title | Safety and Efficacy of Radiofrequency Catheter Ablation of Atrial Fibrillation Drivers as Identified by Fractionated Atrial Potentials (FrAP) Mapping, Using the Rhythmia 3-D Mapping System in Patients with Recurrent Atrial Fibrillation After Prior Pulmonary Vein Isolation Procedure |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2024/01/15 12:30:48 |
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Basic information
Public title
Safety and Efficacy of Radiofrequency Catheter Ablation of Atrial Fibrillation Drivers as Identified by Fractionated Atrial Potentials (FrAP) Mapping,
Using the Rhythmia 3-D Mapping System in Patients with Recurrent Atrial Fibrillation
After Prior Pulmonary Vein Isolation Procedure
Acronym
FrAP- Ablation Study
Scientific Title
Safety and Efficacy of Radiofrequency Catheter Ablation of Atrial Fibrillation Drivers as Identified by Fractionated Atrial Potentials (FrAP) Mapping,
Using the Rhythmia 3-D Mapping System in Patients with Recurrent Atrial Fibrillation
After Prior Pulmonary Vein Isolation Procedure
Scientific Title:Acronym
FrAP- Ablation Study
Region
| Japan | North America |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy and safety of Frap ablation in patients with recurrent atrial fibrillation after PV isolation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Freedom from atrial fibrillation, atrial flutter or atrial tachycardia during 1-year after catheter ablation procedure.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
In addition to pulmonary vein re-isolation, Frap ablation is performed.
Interventions/Control_2
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, having histories of prior catheter ablation (mainly PV isolation), with Symptomatic atrial fibrillation.
2) Documentation of AF between the previous session and the enrollment of the study.
3) Refractory or intolerent to antiarrhythmic drugs.
Key exclusion criteria
1)Initial procedure failed to isolate one or more PVs
2)Left atrial size > 6.1 cm (Anterior-Posterior Dimension)
3)LVEF <35 %
4)Severe mitral regurgitation
5)Prior mitral valve surgery with mechanical valve replacement
6)Intracardiac thrombus present on pre-procedure TTE, TEE. or CT
7)Preexisting severe pulmonary vein stenosis (>75% narrowing)
8)Comorbidity with life-expectancy < 2 years
9)Unable to be on anticoagulation for the purpose of stroke prevention
10)Untreated thyroild dysfunction
11)End-stage renal disease (eGFR<15 or requirement of hemodialysis)
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Sakamoto |
Organization
Toyohashi Heart Center
Division name
Cardiovascular medicine
Zip code
441-8530
Address
21-1 Gobudori, Oyama-cho, Toyohashi
TEL
0532373377
sakamoto@heart-center.or.jp
Public contact
Name of contact person
| 1st name | Yuichiro |
| Middle name | |
| Last name | Sakamoto |
Organization
Toyohashi Heart Center
Division name
Cardiovascular medicine
Zip code
441-8530
Address
21-1 Gobudori, Oyama-cho, Toyohashi
TEL
0532373377
Homepage URL
sakamoto@heart-center.or.jp
Sponsor or person
Institute
Toyohashi Heart Center
Institute
Department
Personal name
Funding Source
Organization
None
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
Toyohashi Heart Center
Address
21-1 Gobudori, Oyama-cho, Toyohashi
Tel
0532373377
heart-chiken@heart-center.or.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
豊橋ハートセンター（愛知県）、名古屋ハートセンター（愛知県）、小倉記念病院（福岡県）、県立尼崎総合医療センター（兵庫県）、一宮西病院（愛知県）、クリーブランドクリニック（オハイオ州）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | 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
| 2021 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 01 | 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
| 2021 | Year | 07 | Month | 08 | Day |
Last modified on
| 2024 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051156
