UMIN-CTR Clinical Trial

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
Last 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
1st 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