UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051837 |
|---|---|
| Receipt number | R000058116 |
| Scientific Title | "Effect of generator impedance during local impedance-guided ablation for atrial fibrillation: a single-center prospective trial" |
| Date of disclosure of the study information | 2023/08/05 |
| Last modified on | 2024/02/04 09:49:16 |
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Basic information
Public title
"Effect of generator impedance during local impedance-guided ablation for atrial fibrillation: a single-center prospective trial"
Acronym
"Effect of generator impedance during local impedance-guided ablation for atrial fibrillation: a single-center prospective trial"
Scientific Title
"Effect of generator impedance during local impedance-guided ablation for atrial fibrillation: a single-center prospective trial"
Scientific Title:Acronym
"Effect of generator impedance during local impedance-guided ablation for atrial fibrillation: a single-center prospective trial"
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effect of generator impedance value on ablation lesion size in local impedance-guided radiofrequency catheter ablation of atrial fibrillation (AF).
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to investigate the effect of generator impedance value on the size of ablation foci in radiofrequency catheter ablation of atrial fibrillation (AF) using local impedance as an indicator.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pulmonary vein isolation is performed while varying the generator impedance by switching the number of counter electrodes, and the relationship between local impedance reduction at adjacent sites and generator impedance is analyzed using data automatically recorded on the RhythmiaTM mapping system workstation.
Key secondary outcomes
Other parameters related to the ablation and their relation to generator impedance are also analyzed using ablation data automatically recorded on the RhythmiaTM mapping system workstation.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
The Rhythmia HDx mapping system and IntellaNav Stablepoint catheter are used for PVI. Before starting the ablation, a voltage map of the area around the pulmonary vein is created to assess the morphology of the left atrium and the degree of degeneration. Before starting PVI, check the generator impedance with one or two effective counter electrodes. The generator impedance varies depending on the body size, etc. If the value is high, the position of the counter electrodes should be adjusted, since there is concern about a decrease in current-carrying efficiency if the value is high. In principle, the generator impedance value is expected to be higher with a single counter electrode if other conditions are the same. Only the ablation of the anterior wall of the left pulmonary vein and the anterior/posterior walls of the right pulmonary vein are the subject of this study. In the usual treatment, the number of effective counter electrodes during a session is fixed at 1 or 2 (both of which are approved in the package insert), but in this intervention study, the number of effective counter electrodes is changed continuously, alternating between 1 (high generator impedance) and 2 (low generator impedance) for each ablation. The counter electrodes are always attached, and the connection between the second counter electrode cable and the generator is connected or disconnected at each ablation to enable or disable the second counter electrode. The basic power output is 40 W. However, if the local impedance drop is rapid, the output can be reduced at the operators' discretion due to the risk of a pop phenomenon. In principle, the goal is to reduce the local impedance by approximately 20-30 ohm with 40 W. If the value is not acquired, the ablation time is extended up to approximately 20-30 seconds. The target contact force is 5-15g, and the target inter-lesion distance is 4mm-5mm.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
AF ablation case with RFCA using the Rhythmia mapping system and IntellaNav Stablepoint RFCA catheter (Boston scientific) and initial PVI.
Key exclusion criteria
Under 20 years of age
Contraindication to ablation therapy
Contraindication to anticoagulation
Pregnancy
Cases in which consent could not be obtained
Other cases that the attending physician deems inappropriate
Patients participating in other clinical trials
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Oka |
| Middle name | |
| Last name | Takafumi |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
+81-6-6879-3640
oka.takafumi.med@osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Sekihara |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
565-08071
Address
2-2 Yamadaoka, Suita, Osaka
TEL
+81-6-6879-3640
Homepage URL
sekihara.t@cardiology.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka university Hospital Institutional Review Board
Address
2-2 Yamadaoka, Suita, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.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
| 2023 | Year | 08 | Month | 05 | 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
| 2023 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 10 | 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
| 2023 | Year | 08 | Month | 05 | Day |
Last modified on
| 2024 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058116
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