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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035012
Receipt No. R000039921
Scientific Title Is a Vagal Response during Left Atrial Ganglionated Plexi Stimulation a Normal Phenomenon?
Date of disclosure of the study information 2018/11/27
Last modified on 2019/12/27

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Basic information
Public title Is a Vagal Response during Left Atrial Ganglionated Plexi Stimulation a Normal Phenomenon?
Acronym Impact of the Vagal Response by Ganglionated Plexi Stimulation
Scientific Title Is a Vagal Response during Left Atrial Ganglionated Plexi Stimulation a Normal Phenomenon?
Scientific Title:Acronym Impact of the Vagal Response by Ganglionated Plexi Stimulation
Region
Japan

Condition
Condition Atrial fibrillation, Wolff-Parkinson-White syndrome
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the vagal reactions by high-frequency stimulation to the left atrial ganglionated plexi in patients with atrial fibrillation(AF) to the patients without AF who underwent ablation of left accessory pathway.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Prevalence of the active GP sites in each major GP area, and the maximum RR interval during high-frequency stimulation
2. Total number of positive vagal response sites by high-frequency stimulation to 15 major left atrial ganglionated plexi sites
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
18 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Atrial fibrillation / Atrioventricular reentrant tachycardia who underwent ablation of left side accessory pathway
Key exclusion criteria History of previous radiofrequency ablation and who had significant valvular heart disease, congenital heart disease diagnosed on echocardiography, or who had thyroid disease
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yasuo
Middle name
Last name Okumura
Organization Division of Cardiology, Department of Medicine, Nihon University School of Medicine
Division name Nihon University Itabashi Hospital
Zip code 173-8610
Address 30-1 Ohyaguchi, Kamicho, Itabashi-Ku, Tokyo, Japan
TEL +81-3-3972-8111
Email yasuwo128@yahoo.co.jp

Public contact
Name of contact person
1st name Kazuki
Middle name
Last name Iso
Organization Division of Cardiology, Department of Medicine, Nihon University School of Medicine
Division name Nihon University Itabashi Hospital
Zip code 173-8610
Address 30-1 Ohyaguchi, Kamicho, Itabashi-Ku, Tokyo 173-8610, Japan
TEL +81-3-3972-8111
Homepage URL
Email heartilly.dr.ka2-0603@hotmail.co.jp

Sponsor
Institute Division of Cardiology, Department of Medicine, Nihon University School of Medicine
Institute
Department

Funding Source
Organization Division of Cardiology, Department of Medicine, Nihon University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nihon University Itabashi Hospital, Clinical Research Judging Committee
Address 30-1 Ohyaguchi, Kamicho, Itabashi-Ku, Tokyo 173-8610, Japan
Tel +81-3-3972-8111
Email med.itabashi.chiken@nihon-u.ac.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
2018 Year 11 Month 27 Day

Related information
URL releasing protocol http://www.med.nihon-u.ac.jp/hospital/itabashi/cr/pdf/RK-190706-1.pdf
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/31610720
Number of participants that the trial has enrolled 63
Results
Overall, more active-GP areas were found in the AF group patients than in the non-AF group patients, and at all 5 major GPs, the maximum R-R interval during HFS was significantly prolonged in the AF patients. After multivariate adjustment, association was established between the total number of vagal response sites and the presence of AF.
Results date posted
2019 Year 12 Month 27 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Included in the study were 42 consecutive patients with AF undergoing extensive encircling PVI (AF group) and 21 age-matched patients with AVRT undergoing ablation of a left side accessory pathway (non-AF group). All were treated at Nihon University Itabashi Hospital between August 2013 and October 2017. Patients who had undergone RF ablation previously and those with significant valvular heart disease, congenital heart disease diagnosed echocardiographically, or thyroid disease were not included in the study, and no patient with a history of AF was included in the non-AF group. Twenty-eight patients in the AF group had paroxysmal AF, i.e., AF lasting 7 days or fewer, and 14 had persistent AF, i.e., AF lasting more than 7 days. All patients in this group had been on adequate oral anticoagulation therapy for at least 1 month before the ablation procedure, and for both the AF patients and non-AF patients all antiarrhythmic drugs had been discontinued for at least 5 half-lives before the procedure. Transesophageal echocardiography was performed in all patients in the AF group, and transthoracic echocardiography was performed in all patients in both groups.
Participant flow
Electrophysiology study was performed with patients under conscious sedation, which was achieved with propofol, fentanyl, and dexmedetomidine in patients with AF and with midazolam and fentanyl in those with AVRT. After vascular access was obtained, single transseptal puncture was performed, and intravenous heparin was administered for maintenance of an activated clotting time of >300 seconds in all patients.
Twenty-nine of the 42 patients in the AF group underwent PVI by means of contact force-guided RF ablation, and the remaining 13 patients underwent second-generation cryoballoon-based PVI. Details of the 2 ablation procedures were as described elsewhere. The left atrium (LA) and 4 PVs were reconstructed 3-dimensionally with a CARTO 3 mapping system (Biosense Webster, Diamond Bar, CA, USA) or an EnSite NavX velocity mapping system (St. Jude Medical, Minneapolis, MN, USA). In the non-AF patients, electrode catheters were positioned at the high right atrium, at the His bundle, and in the coronary sinus (CS), with the proximal electrode of the CS catheter positioned at the CS ostium. A 7-Fr deflectable catheter with a 4-mm ablation tip (Therapy; St. Jude Medical, West Berlin, NJ, USA) was advanced into the LA via the single transseptal puncture. 
HFS-based evaluation of the LA GPs was performed before ablation in the AF patients and after successful ablation in the non-AF patients. Guided by the 3D geometric map, we placed the ablation catheter at the presumed anatomical area of each of the 5 major GPs in the LA: the ARGP, IRGP, SLGP, ILGP, and Marshall tract GP. Endocardial HFS (MicroPace EPS320 cardiac stimulator, Mictopace EP Inc.; 20 Hz; output, 25 mA; pulse duration, 10 ms) was performed at 3 different sites within the anatomical area of each of the 5 major GPs. The stimulation was generally performed for 5 seconds, but it was performed for less than 5 seconds if GP activity occurred immediately upon energy delivery. A vagal response was defined as prolongation of the maximum R-R interval by >50% (in comparison to the mean pre-HFS R-R interval averaged over 10 beats) in association with a sudden >20 mmHg decrease in blood pressure (documented by means of continuous invasive arterial monitoring), and the HFS response site was marked on the 3D geometric map. In addition, active-GP areas, defined as GP areas in which 1 or more vagal responses were provoked, were noted.
Adverse events
none
Outcome measures
We compared the following variables between in the AF patients and non-AF patients: clinical characteristics of the patients at the time of ablation, the percentage (ratio) of sites at which a vagal response was elicited by HFS (for a possible total of 15: 3 sites within each GP area * 5 major LA GPs); percentage (ratio) of patients in whom HFS elicited a vagal response, per GP area; and the maximum R-R interval recorded during HFS. We also compared the percentage (ratio) of sites at which a vagal response was elicited by HFS between patients without AF, patients with paroxysmal A, and patients with persistent AF and also between patients in whom AF was sustained, i.e., lasted more than 5 minutes, after the final HFS and those in whom it was not sustained.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 08 Month 03 Day
Date of IRB
2019 Year 07 Month 12 Day
Anticipated trial start date
2013 Year 08 Month 23 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 54 patients were enrolled in this study

Management information
Registered date
2018 Year 11 Month 26 Day
Last modified on
2019 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039921

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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