Intracardiac Echocardiography Guided vs. Electroanatomical Mapping System Guided Slow Pathway Ablation in Patients With Atrioventricular Nodal Reentrant Tachycardia
NCT05907863 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2023-06-18
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).
Conditions
- Heart Rhythm Disorder
Interventions
- OTHER
-
Use of intracardiac echocardiography
intracardiac echocardiography guided slow pathway ablation in patients with AVNRT
Sponsors & Collaborators
-
University of Pecs
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-04-01
- Primary Completion
- 2023-04-01
- Completion
- 2023-04-01
Countries
- Hungary
Study Locations
More Related Trials
-
High-density Activation Mapping of the Slow Pathwayto Guide Catheter Ablation in Patients With Typical Atrioventricular Nodal Reentrant Tachycardia
NCT05531903 ·Status: COMPLETED ·Phase: NA
-
European Multicenter Study Radiofrequency (RF) Versus Cryo in Atrioventricular Nodal Reentry Tachycardia (AVNRT)
NCT00196222 ·Status: COMPLETED ·Phase: PHASE4
-
Utility of ICD Electrograms During Ventricular Tachycardia Ablation
NCT02274168 ·Status: COMPLETED ·Phase: NA
-
Ventricular Tachycardia in Ischemic Cardiomyopathy; a Combined Endo-Epicardial Ablation Within the First Procedure Versus a Stepwise Approach
NCT02358746 ·Status: UNKNOWN ·Phase: NA
-
The Effect of Low LEVel TrAgus STimulation on the Electrophysiological Substrate of Patients With Ischemic CardioMyopathy Substrate of Subjects With Ischemic CardioMyopathy
NCT03549468 ·Status: COMPLETED ·Phase: NA
-
AV Nodal Reentrant Tachycardia Study
NCT00618683 ·Status: COMPLETED ·Phase: NA
-
Imaging With a Radio Tracer to Guide VT Ablations
NCT01250912 ·Status: COMPLETED ·Phase: NA
-
Early Ablation Therapy for the Treatment of Ischemic Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillators
NCT01557842 ·Status: TERMINATED ·Phase: PHASE4
-
Noninvasive Electrocardiographic Imaging for Individuals at Risk for Apparently Idiopathic Ventricular Fibrillation.
NCT03963271 ·Status: UNKNOWN
-
Routine Mini-invasive Electrophysiology Study for Patients Feeling Tachycardia, With a Negative Holter ECG
NCT00251121 ·Status: COMPLETED ·Phase: NA
-
Real-Time Intracardiac Echocardiography for Ventricular Arrhythmia Ablation
NCT07201506 ·Status: RECRUITING ·Phase: NA
-
Left Ventricular Septum Pacing in Patients by Transvenous Approach Through the Inter-ventricular Septum
NCT01609738 ·Status: COMPLETED
-
Preventive VT Substrate Ablation in Ischemic Heart Disease
NCT04675073 ·Status: RECRUITING ·Phase: PHASE3
-
Changes in Myocardial Perfusion During Chronic Multi Site Biventricular Versus Right Ventricular Apex Pacing in Patients With Normal Left Ventricular Function Undergoing His Bundle Ablation for Drug-refractory Atrial Fibrillation
NCT00528307 ·Status: TERMINATED ·Phase: NA
-
Effect of Multielectrode Versus Point-by-Point Mapping on Recurrence of Ventricular Tachycardia in Ischemic Heart Disease
NCT05203484 ·Status: SUSPENDED ·Phase: NA
-
A Study of Early Robotic Ablation by Substrate Elimination of Ventricular Tachycardia
NCT01182389 ·Status: COMPLETED ·Phase: NA
-
Non-invasive Ablation of Ventricular Tachycardia
NCT03601832 ·Status: COMPLETED ·Phase: NA
-
Primary Preventive Ventricular Tachycardia Ablation In High-Risk Patients Who Receive A Prophylactic Implantable Cardioverter Defibrillator
NCT06543173 ·Status: RECRUITING ·Phase: NA
-
Ultra-high Density Mapping With Multielectrode Catheter vs Conventional Point by Point Mapping for Ventricular Tachycardia Substrate Ablation
NCT02083016 ·Status: COMPLETED ·Phase: PHASE4
-
Substrate Modification in Stable Ventricular Tachycardia in Addition to Implantable Cardioverter Defibrillator (ICD) Therapy
NCT00919373 ·Status: COMPLETED ·Phase: NA
-
Differentiate AVNRT from Orthodromic AVRT
NCT06671145 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Non-invasive Differentiation of Supraventricular Tachyarrhythmia
NCT06061120 ·Status: RECRUITING
-
Iv Amiodarone Versus Iv Procainamide to Treat Haemodynamically Well Tolerated Ventricular Tachycardia
NCT00383799 ·Status: TERMINATED ·Phase: PHASE4
-
Impact of Catheter Ablation of Frequent Premature Ventricular Complexes in Treating Subtle Left Cardiomyopathy
NCT06864429 ·Status: COMPLETED ·Phase: NA
-
Atropine vs Isoprenaline in the Invasive Diagnosis of Arrhythmias
NCT06082388 ·Status: NOT_YET_RECRUITING ·Phase: NA