UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050344 |
|---|---|
| Receipt number | R000057209 |
| Scientific Title | PRospEctive multiCenter registry to InveStigate the clinical fEasibility of COMBination wOrkflow with 90W/4sec and Ablation index-guided 50W ablation (PRECISE-COMBO 90W/50W study) |
| Date of disclosure of the study information | 2023/02/15 |
| Last modified on | 2023/09/24 12:51:05 |
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Basic information
Public title
PRospEctive multiCenter registry to InveStigate the clinical fEasibility of COMBination wOrkflow with 90W/4sec and Ablation index-guided 50W ablation (PRECISE-COMBO 90W/50W study)
Acronym
PRECISE-COMBO 90W/50W study
Scientific Title
PRospEctive multiCenter registry to InveStigate the clinical fEasibility of COMBination wOrkflow with 90W/4sec and Ablation index-guided 50W ablation (PRECISE-COMBO 90W/50W study)
Scientific Title:Acronym
PRECISE-COMBO 90W/50W study
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study will be to investigate the clinical feasibility of a combined ablation strategy with 90W/4sec-vHPSD and AI-guided 50W-HPSD for a PVI in patients with paroxysmalatrial fibrillation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
success rate of first-pass pulmonary vein isolation
Key secondary outcomes
1) dormant conduction rate and sites
2) chronic recurrence rate 1 year after catheter ablation.
3) the success rate of first-pass pulmonary vein isolation and the reduction in operative duration by optimization of 90W/50W combination
4) incidence of ablation-related adverse events (cardiac tamponade, ischemic heart disease, stroke, gastro-esophageal disorders [gastric peristalsis, esophageal perforation], vascular injury, major bleeding events meeting ISTH criteria other than cardiac tamponade or clinically significant bleeding) during the peri-ablation period [up to 1 month post-operatively]
5) frequency of 40 dgree rise in esophageal temperature and the maximum esophageal temperature during ablation
6) the relationship between the sites of pulmonary vein reconnection and patient background, ablation conditions, energization index, energization interval, intracardiac potentials and wall thickness on CT image
7) changes in symptoms and QoL from enrolment to 1 year
8) MACE (total mortality, non-fatal myocardial infarction, non-fatal stroke)
9) total mortality
10) cardiovascular death
11) non-fatal myocardial infarction
12) non-fatal cerebral infarction
13) heart failure
14) pacemaker implantation
15) major bleeding event meeting ISTH criteria (fatal hemorrhage, intracranial hemorrhage, intrathecal hemorrhage, intrathecal hemorrhage, intraocular hemorrhage, intrapericardial hemorrhage, intra-articular hemorrhage intramuscular hemorrhage with compartment syndrome, retroperitoneal hemorrhage, gastrointestinal hemorrhage hemoglobin level falls by greater than or equal to 20 g/L (1.24 mmol/L) bleeding, bleeding requiring transfusion of more than 2 units of whole blood or red blood cells)
16) clinically significant bleeding
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients undergoing initial catheter ablation for paroxysmal atrial fibrillation between the date of approval and 30 June 2024 at the Division of Cardiology, Department of Medicine, Nihon University School of Medicine, and collaborating institutions.
Patients who have been fully informed about their participation in the study and who have given their free and voluntary written consent with full understanding.
Key exclusion criteria
1) Patients with persistent atrial fibrillation.
2) Patients with a history of ablation
3) Patients who have difficulty in taking oral medication
4) Patients on dialysis
5) Patients with severe valvular heart disease
6) Patients who have difficulty in obtaining consent in person
7) Patients who have refused to participate in this study.
8) Any other Patients who are judged by the principal investigator to be unsuitable as a research subjects.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Okumura |
Organization
Nihon University School of Medicine
Division name
Division of Cardiology, Department of Medicine
Zip code
1738610
Address
30-1 Ohyaguchi, Kamicho, Itabashi-Ku, Tokyo 173-8610, Japan
TEL
+81-3-3972-8111
okumura.yasuo@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryuta |
| Middle name | |
| Last name | Watanabe |
Organization
Nihon University School of Medicine
Division name
Division of Cardiology, Department of Medicine
Zip code
1738610
Address
30-1 Ohyaguchi, Kamicho, Itabashi-Ku, Tokyo 173-8610, Japan
TEL
+81-3-3972-8111
Homepage URL
watanabe.ryuta@nihon-u.ac.jp
Sponsor or person
Institute
Division of Cardiology, Department of Medicine, Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Biosense Webster, Inc. part of the Johnson & Johnson Family of Companies
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Itabashi Hospital Clinical Research Center
Address
30-1 Oyaguchi-Kami Itabashi-Ku
Tel
03-3972-8111(8476)
komoda.nozomi@nihon-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
弘前大学医学附属病院（青森県）、済生会熊本病院（熊本県）、筑波大学附属病院（茨城県）、小倉記念病院（福岡県）、昭和大学江東豊洲病院（東京都）、豊橋ハートセンター（愛知県）、東京ハートリズムクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate perioperative acute success rates, complications and chronic success rates of ablation with a combination workflow using an Ablation index-guided 50 W HPSD setting and a 90 W/4 s vHPSD setting in a multicentre setting.
Management information
Registered date
| 2023 | Year | 02 | Month | 15 | Day |
Last modified on
| 2023 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057209
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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