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Intracardiac Echocardiography Guided vs. Electroanatomical Mapping System Guided Slow Pathway Ablation in Patients With Atrioventricular Nodal Reentrant Tachycardia

Primary Purpose

Heart Rhythm Disorder

Status
Completed
Phase
Phase 4
Locations
Hungary
Study Type
Interventional
Intervention
Use of intracardiac echocardiography
Sponsored by
University of Pecs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Rhythm Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients with documented paroxysmal supraventricular tachycardias Exclusion Criteria: redo procedures pregnancy age under 18 other arrhythmias in addition to AVNRT

Sites / Locations

  • University of Pecs

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intracardiac echo guided ablation

Standard, electroanatomical mapping system guided ablation

Arm Description

Outcomes

Primary Outcome Measures

procedural time

Secondary Outcome Measures

ablation time
fluoroscopy useage

Full Information

First Posted
June 8, 2023
Last Updated
June 8, 2023
Sponsor
University of Pecs
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1. Study Identification

Unique Protocol Identification Number
NCT05907863
Brief Title
Intracardiac Echocardiography Guided vs. Electroanatomical Mapping System Guided Slow Pathway Ablation in Patients With Atrioventricular Nodal Reentrant Tachycardia
Official Title
Intracardiac Echocardiography Guided vs. Electroanatomical Mapping System Guided Slow Pathway Ablation in Patients With Atrioventricular Nodal Reentrant Tachycardia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
April 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pecs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Study protocol To prepare for the electrophysiologic study, antiarrhythmic drugs were discontinued at least five half-lives before the procedure and were under conscious sedation using midazolam ± fentanyl while fasting. ICE-guided ablation group In patients randomized to ICE-guided ablation group, catheter placement was initially performed using fluoroscopy guidance, after local anesthesia. A decapolar steerable catheter was placed in the coronary sinus (CS), a quadripolar electrode catheter was positioned in the right ventricular apex and an ablation catheter was inserted to record the His bundle electrogram. Twelve-lead electrocardiogram and intracardiac electrograms were recorded and saved on a digital recording system using a band pass filter of 30 to 500 Hz. Electrical stimulation techniques were used to test atrioventricular nodal conduction and induce AVNRT, with the S2 coupling interval being gradually shortened after each drive-train until tachycardia was induced, AV conduction block occurred, or the atrial refractory period was reached. If tachycardia was not inducible, isoprenaline infusion was given to increase the heart rate by at least 20%, and the same stimulation protocol was repeated during both the infusion and washout phases. The diagnosis of AVNRT was made using established electrophysiologic criteria and pacing maneuvers. This involved assessing the A-(H)-V response after ventricular overdrive pacing, with an SA-VA interval greater than 85 ms, and a corrected postpacing interval minus tachycardia cycle length greater than 110 ms. After confirmation of the diagnosis of AVNRT through the diagnostic EP study, the quadripolar electrode catheter was removed and replaced with an 8F ICE catheter for mapping and SP ablation. The echo-transducer was positioned in the low right atrium at the 6 o'clock position and rotated clockwise towards the septum to allow for visualization of the anatomic landmarks. The proximity of the ablation catheter to the compact AV node was determined by the distance from the aortic valve, which marks the recording site of a proximal His potential. In cases of ineffective ablation, the catheter was moved closer to the aortic valve, but always maintaining a distance of at least 0.5 cm, and RF application was attempted again. RF energy was delivered starting just below the CS with a power output of 30 W and a preset temperature of 55°C. Effective applications were continued for 30 to 60 s and considered successful when junctional rhythm appeared. RF application was immediately halted if there was catheter displacement, sudden impedance rise, prolongation of PR interval, anterograde AV or retrograde VA block. Electroanatomical mapping system -guided ablation group An ablation catheter was inserted into the heart to create an anatomical map by CARTO of the right atrium after local anesthesia, and the location of the His bundle was tagged. Decapolar and quadripolar diagnostic catheters were positioned thereafter into appropriate position as described above. After confirming the diagnosis of AVNRT, mapping of the slow pathway was started by NAVISTAR catheter guided by EAMS and aiming at an atrial-to-ventricular electrogram amplitude ratio of 1:3-1:5. If the ablation endpoint was not reached after 8 radiofrequency (RF) applications, patients in the EMAS-guided ablation group were allowed to crossover to an ICE-guided procedure. The ablation procedure was deemed successful if, following a 20-minute waiting period, the arrhythmia failed to be induced and there were no instances of more than one echo beat observed, both in the presence and absence of isoprenaline. The procedure time was measured from the initial femoral puncture until the withdrawal of the catheters. The mapping plus ablation time was calculated from the start of the SP mapping until the end of the last attempted ablation. Fluoroscopy time, radiation dose, and dose-area product (DAP) were automatically recorded by the fluoroscopy system. The ablation data, including the total number of RF applications, sum of delivered RF energy in Watts, and the total ablation time in seconds, were calculated and stored by the EP recording system (CardioLab, GE Healthcare).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Rhythm Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intracardiac echo guided ablation
Arm Type
Experimental
Arm Title
Standard, electroanatomical mapping system guided ablation
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Use of intracardiac echocardiography
Intervention Description
intracardiac echocardiography guided slow pathway ablation in patients with AVNRT
Primary Outcome Measure Information:
Title
procedural time
Time Frame
during the procedure
Secondary Outcome Measure Information:
Title
ablation time
Time Frame
during the procedure
Title
fluoroscopy useage
Time Frame
during the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with documented paroxysmal supraventricular tachycardias Exclusion Criteria: redo procedures pregnancy age under 18 other arrhythmias in addition to AVNRT
Facility Information:
Facility Name
University of Pecs
City
Pecs
Country
Hungary

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intracardiac Echocardiography Guided vs. Electroanatomical Mapping System Guided Slow Pathway Ablation in Patients With Atrioventricular Nodal Reentrant Tachycardia

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