UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021127 |
|---|---|
| Receipt number | R000023208 |
| Scientific Title | Comparison between Contact Force Monitoring and Unipolar Signal Modification as a Guide for Catheter Ablation of Atrial Fibrillation: A Prospective Multi-centre Randomized Controlled Study (COMPASS study) |
| Date of disclosure of the study information | 2016/02/21 |
| Last modified on | 2019/02/24 18:47:01 |
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Basic information
Public title
Comparison between Contact Force Monitoring and Unipolar Signal Modification as a Guide for Catheter Ablation of Atrial Fibrillation: A Prospective Multi-centre Randomized Controlled Study (COMPASS study)
Acronym
Comparison between Contact Force Monitoring and Unipolar Signal Modification as a Guide for Catheter Ablation of Atrial Fibrillation: A Prospective Multi-centre Randomized Controlled Study (COMPASS study)
Scientific Title
Comparison between Contact Force Monitoring and Unipolar Signal Modification as a Guide for Catheter Ablation of Atrial Fibrillation: A Prospective Multi-centre Randomized Controlled Study (COMPASS study)
Scientific Title:Acronym
Comparison between Contact Force Monitoring and Unipolar Signal Modification as a Guide for Catheter Ablation of Atrial Fibrillation: A Prospective Multi-centre Randomized Controlled Study (COMPASS study)
Region
| Japan |
Condition
Condition
Paroxysmal atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effectiveness between contact force monitoring and unipolar signal modification as a guide for catheter ablation (pulmonary vein isolation) of atrial fibrillation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ablation success at 1 after after the index procedure. The definition of recurrence; any atrial tachyarrhythmia lasting more than 30 seconds after 3 month after the index procedure. The definition of procedural success; no recurrence without any anti-arrhythmic drugs.
Key secondary outcomes
1) acute left atrium-pulmonary vein electrical reconnection (time-dependent/ATP-dependent)
2) ablation time
3) energy
4) procedural time
5) complication associated with the procedure
6) contact force value
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Every single RF application will be performed under CF guidance. Target CF of 20 g (with range of 10-30 g) and minimum FTI (force time integral) of 400 g s. VisiTag is utilized to visualize the catheter position stability and FTI.
Interventions/Control_2
Every single RF application will be lasted at least 5 seconds after the unipolar atrial EGM, recorded by the ablation catheter, which always demonstrates positive-negative morphology before ablation, became complete positive signal. VisiTag is utilized to visualize the catheter position stability.
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
Patients with paroxysmal atrial fibrillation who will undergo radio-frequency catheter ablation
Key exclusion criteria
1) Persistent AF
2) Prior left atrial ablation (surgical or catheter)
3) Left atrial volume >50mm
4) Left ventricular ejection fraction <40%
5) Contraindication to anticoagulation medications
6) Severe pulmonary disease
7) Maintenance dialysis to chronic renal insufficiency
Target sample size
138
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuhisa Hagiwara |
Organization
Tokyo Women's Medical University
Division name
Cardiology
Zip code
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo, JAPAN
TEL
03-3353-8111
mhagi@hij.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichiro Ejima |
Organization
Tokyo Women's Medical University
Division name
Cardiology
Zip code
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo, JAPAN
TEL
03-3353-8111
Homepage URL
koichiro@qf6.so-net.ne.jp
Sponsor or person
Institute
Department of Cardiology, Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiology, Tokyo Women's Medical University
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
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
1. Department of Cardiology, Tokyo Women’s Medical University, Tokyo, Japan.
2. Department of Cardiology, Tokyo Metropolitan Tama Medical Center, Tokyo, Japan.
3. Department of Cardiology, Shinshu University, Matsumoto, Japan.
4. Department of Cardiology, Oita Medical Center, Oita, Japan.
5. Department of Arrhythmia, Kanazawa Cardiovascular Hospital, Kanazawa, Japan.
6. Department of Cardiology, Kagawa University, Takamatsu, Japan.
7. Department of Cardiology, Suwa Central Hospital, Chino, Japan.
8. Department of Cardiology, Takamatsu Red Cross Hospital, Takamatsu, Japan.
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 21 | 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
Unipolar signal modification was superior to contact force monitoring as an endpoint for radiofrequency energy deliveries during pulmonary vein isolation in patients with paroxysmal atrial fibrillation in terms of the 12-month recurrence free rate (85% vs. 70%, p=0.031).
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
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 21 | Day |
Last modified on
| 2019 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023208
