UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055743 |
|---|---|
| Receipt number | R000063699 |
| Scientific Title | FARAPULSE Pulsed Field Ablation System Post-Market Surveillance Study |
| Date of disclosure of the study information | 2024/11/01 |
| Last modified on | 2025/10/06 16:13:36 |
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Basic information
Public title
FARAPULSE Pulsed Field Ablation System Post-Market Surveillance Study
Acronym
FARAPULSE Pulsed Field Ablation System Post-Market Surveillance Study
Scientific Title
FARAPULSE Pulsed Field Ablation System Post-Market Surveillance Study
Scientific Title:Acronym
FARAPULSE Pulsed Field Ablation System Post-Market Surveillance Study
Region
| Japan |
Condition
Condition
Paroxysmal Atrial Fibrillation
Classification by specialty
| Cardiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirm the safety and effectiveness of FARAPULSE system in the routine clinical practice after the marketing approval.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Composite Safety Endpoint (CSE)
defined as one or more of the following device-or procedure-related SAEs;
- Any of the following with an Onset Date within 7 days of the Index procedure:
- Death
- Myocardial infarction
- Persistent phrenic nerve palsy
- Stroke
- Transient ischemic attack (TIA)
- Peripheral or organ thromboembolism
- Cardiac tamponade / perforation
- Pericarditis
- Pulmonary edema
- Vascular access complications
- Heart block
- Gastric motility/pyloric spasm disorders
Either of the following with an Onset Date at any time through the completion of 12-month follow-up visit
- PVS
- Atrio-esophageal fistula
Treatment Success from the index procedure through the completion of 12-month follow-up visit
Key secondary outcomes
Safety (AE, Device Deficiencies and mortality), demographics, device information, procedure information, medication
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients intended to be treated with FARAPULSE Pulsed Field Ablation System
Key exclusion criteria
Not Applicable
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Kawahara |
Organization
Boston Scientific Japan K.K.
Division name
Clinical Affairs
Zip code
164-0001
Address
4-10-2 Nakano, Nakano-ku, Tokyo, Japan
TEL
03-6853-7500
Kazuo.Kawahara@bsci.com
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Sakamoto |
Organization
Boston Scientific Japan K.K.
Division name
Clinical Affairs
Zip code
164-0001
Address
4-10-2 Nakano, Nakano-ku, Tokyo, Japan
TEL
03-6853-7500
Homepage URL
Hiroshi.Sakamoto@bsci.com
Sponsor or person
Institute
Boston Scientific Japan K.K.
Institute
Department
Personal name
Funding Source
Organization
Boston Scientific Japan K.K.
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
Not applicable
Address
Not applicable
Tel
Not applicable
Not applicable
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
| 2024 | Year | 11 | 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
305
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
| 2024 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2028 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not Applicable
Management information
Registered date
| 2024 | Year | 10 | Month | 04 | Day |
Last modified on
| 2025 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063699
