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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036168
Receipt No. 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

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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
Email 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
Email akio.chikata@gmail.com

Sponsor
Institute Toyama Prefectural Central Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041180

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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