UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061988 |
|---|---|
| Receipt number | R000068907 |
| Scientific Title | High-flow nasal cannula versus noninvasive positive pressure ventilation for pulsed field ablation with deep sedation |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/06/20 15:26:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
High-flow nasal cannula versus noninvasive positive pressure ventilation for pulsed field ablation with deep sedation
Acronym
NHF vs NIV for PFA
Scientific Title
High-flow nasal cannula versus noninvasive positive pressure ventilation for pulsed field ablation with deep sedation
Scientific Title:Acronym
NHF vs NIV for PFA
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we conducted a prospective observational study comparing the safety and efficacy of NHF and NIV during PFA
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint was incidence of hypoxemia (SpO2 < 90%) during two different respiratory management modalities.
Key secondary outcomes
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Consecutive patients who underwent catheter ablation for atrial fibrillation between April 2025 to march 2027
Key exclusion criteria
Patients on renal replacement therapy or those with an eGFR < 30 mL/min/1.73 m2 were excluded. Exclusion criteria also included anaphylaxis, cardiogenic shock, and cases in which intraoperative monitoring of SpO2 or non-invasive blood pressure could not be reliably performed.
Target sample size
280
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Chikata |
Organization
Toyama Prefectural Central Hospital
Division name
Department of Cardiology
Zip code
930-8550
Address
2-2-78 Nishi-nagae, Toyama
TEL
076-424-1531
Akio.Chikata@gmail.com
Public contact
Name of contact person
| 1st name | Akio |
| Middle name | |
| Last name | Chikata |
Organization
Toyama Prefectural Central Hospital
Division name
Department of Cardiology
Zip code
930-8550,
Address
2-2-78 Nishi-nagae, Toyama
TEL
076-424-1531
Homepage URL
Akio.Chikata@gmail.com
Sponsor or person
Institute
Toyama Prefectural Central Hospital,
Institute
Department
Personal name
Funding Source
Organization
Toyama Prefectural Central Hospital,
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
Toyama Prefectural Central Hospital,
Address
2-2-78 Nishi-nagae, Toyama
Tel
076-424-1531
byoin@esp.pref.toyama.lg.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
| 2026 | Year | 09 | 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
282
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
Completed
Date of protocol fixation
| 2025 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To compare the efficacy and safety of high-flow nasal cannula (HFNC) and noninvasive ventilation (NIV) as respiratory management strategies during PFA under deep sedation.
Management information
Registered date
| 2026 | Year | 06 | Month | 20 | Day |
Last modified on
| 2026 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068907
