UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036168 |
|---|---|
| Receipt number | R000041180 |
| Scientific Title | Coronary Sinus Catheter Placement via Left Cubital Vein for Phrenic Nerve Stimulation during Pulmonary Vein Isolation |
| Date of disclosure of the study information | 2019/05/01 |
| Last modified on | 2019/04/09 07:46:29 |
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Basic information
Public title
Coronary Sinus Catheter Placement via Left Cubital Vein for Phrenic Nerve Stimulation during Pulmonary Vein Isolation
Acronym
Left cubital approach for PNP
Scientific Title
Coronary Sinus Catheter Placement via Left Cubital Vein for Phrenic Nerve Stimulation during Pulmonary Vein Isolation
Scientific Title:Acronym
Left cubital approach for PNP
Region
| Japan |
Condition
Condition
Atrial Fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluated the safety of a left cubital vein approach for positioning a 20-electrode atrial cardioversion (BeeAT) catheter in the coronary sinus (CS), and the feasibility of right PN pacing from the superior vena cava (SVC) using paroxysmal electrodes of the BeeAT catheter.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Success rate of phrenic nerve pacing via left cubtai approach
Key secondary outcomes
Complication of left cubtai approach and balloon based pulmonary vein isolation
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
Symptomatic, drug-refractory AF who underwent balloon-based catheter ablation at Toyama Prefectural Central Hospital (Japan) between September 2017 and August 2018 were retrospectively evaluated.
Key exclusion criteria
We excluded patients on maintenance dialysis with left upper limb vascular access and those with cardiac implantable electrical devices inserted with left side venous access because a left cubital approach would be inappropriate for these patients.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Chiakta |
Organization
Toyama Prefectural Central Hospital
Division name
Division of Cardiology, Department of Internal Medicine
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
Division of Cardiology, Department of Internal Medicine
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, Toyama, Japan
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
| 2019 | Year | 05 | 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
106
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
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
CS catheter placement with a left cubital vein approach for right PN stimulation was found to be safe and feasible. Right PN pacing from the SVC using a BeeAT catheter was successfully achieved in the majority of the patients. This approach may prove to be preferable for non-obese patients.
Management information
Registered date
| 2019 | Year | 03 | Month | 12 | Day |
Last modified on
| 2019 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041180
