UMIN-CTR Clinical Trial

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

Atrial fibrillation, Wolff-Parkinson-White syndrome

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

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

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

11

Month

27

Day

URL releasing protocol

http://www.med.nihon-u.ac.jp/hospital/itabashi/cr/pdf/RK-190706-1.pdf

Publication of results

Published

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

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 related information

54 patients were enrolled in this study

Registered date

2018

Year

11

Month

26

Day

Last modified on

2019

Year

12

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039921