CHAZESubstrate: Characterization of Left Atrial Substrate by Comparison of Bipolar Voltage Maps With Standard Focal 4.5 mm Tip Electrode, 1 mm Ring Electrode, and Microelectrode Catheters Using InTEllaMap Orion and IntellaNav MIFI O

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Completed

CT.gov ID

NCT04095559

Collaborator

Boston Scientific Corporation (Industry)

Enrollment

Location

17.8

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to investigate the correlation and to obtain the coefficient of correlation between the global and local bipolar signals (voltage maps) of the LA in sinus rhythm using a focal 4.5 mm irrigated-tip ablation catheter (in combination with microelectrodes), a ring-electrode circular mapping catheter and a microelectrode multipolar catheter in combination with the Rhythmia system.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation (AF)	Diagnostic Test: multipolar mapping catheter Diagnostic Test: multielectrode circular catheter Diagnostic Test: irrigated ablation catheter

Detailed Description

Current hypothesis of the mechanism of atrial fibrillation (AF) is a combination of local firing mainly triggered from the pulmonary veins and atrial substrate due to atrial remodelling sustaining AF. Whereas for paroxysmal AF, pulmonary vein isolation (PVI) is still the mainstay of interventional treatment, a left atrial (LA) substrate-based ablation especially in patients with persistent or long-standing persistent AF may be reasonable to improve freedom from AF. In addition, even in patients with paroxysmal AF, substrate-based ablation strategies have been shown to improve outcome. Substrate characterization of the LA is currently performed using the focal ablation catheter with a 3.5mm irrigated tip catheter with a 2 mm interelectrode spacing, a circular (Lasso) or spider like diagnostic (Pentaray) catheter with 1 mm size of the ring electrodes and 2 mm to 4 mm interelectrode spacing. Consequently, the cut-off values to delineate healthy tissue from diseased substrate are defined based on these measures. Since the electrode size and distance between the electrodes determines the bipolar voltage amplitude and morphology (beside their orientation with regard to the propagation wavefront), differences in bipolar voltage values must be expected between different catheter types and especially for the novel micro-electrode catheters IntellaMap Orion and IntellaNav MIFI OI. With the knowledge of the relationship between the bipolar voltage maps created with the different catheter types, information/knowledge from one study obtained with a specific catheter can be transferred to patients treated with the other catheter types. This study is to investigate the correlation and to obtain the coefficient of correlation between the global and local bipolar signals (voltage maps) of the LA in sinus rhythm using a focal 4.5 mm irrigated-tip ablation catheter (in combination with microelectrodes), a ring-electrode circular mapping catheter and a microelectrode multipolar catheter in combination with the Rhythmia system.

Study Design

Study Type:

Observational

Actual Enrollment :

25 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Characterization of Left Atrial Substrate by Comparison of Bipolar Voltage Maps With Standard Focal 4.5 mm Tip Electrode, 1 mm Ring Electrode, and Microelectrode Catheters Using InTEllaMap Orion and IntellaNav MIFI O

Actual Study Start Date :

Dec 5, 2019

Actual Primary Completion Date :

May 31, 2021

Actual Study Completion Date :

May 31, 2021

Outcome Measures

Primary Outcome Measures

Global bipolar and unipolar signal measured in millivolt (mV) [single time point assessment at baseline]
Global bipolar and unipolar signal for the different types of catheters measured in mV
Local bipolar and unipolar signal measured in mV [single time point assessment at baseline]
Local bipolar and unipolar signal for the different types of catheters measured in mV

Secondary Outcome Measures

Global fibrosis content and distribution from LGE-MRI measured in [%]. [single time point assessment at baseline]
Global fibrosis content and distribution from LGE-MRI measured in [%].
Local fibrosis content and distribution from Late-gadolinium enhanced Magnetic Resonance Imaging (LGE-MRI) measured in [%]. [single time point assessment at baseline]
Local fibrosis content and distribution from LGE-MRI measured in [%].
Differences of bipolar voltage characteristics between nearfield and farfield signals: amplitude (mV) [single time point assessment at baseline]
Differences of bipolar voltage characteristics between nearfield and farfield signals: amplitude (mV)
Differences of bipolar voltage characteristics between nearfield and farfield signals: frequency in Hertz (Hz) [single time point assessment at baseline]
Differences of bipolar voltage characteristics between nearfield and farfield signals: frequency (Hz)
Differences of bipolar voltage characteristics between nearfield and farfield signals: Duration in milliseconds (ms) [single time point assessment at baseline]
Differences of bipolar voltage characteristics between nearfield and farfield signals: duration (ms)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Documented atrial fibrillation
First or repeat catheter ablation

Exclusion Criteria:

Previous heart surgery (high probability for atypical atrial tachycardia and non PV triggers for AF)
Congenital heart disease (corrected or uncorrected)
Severe uncorrected valvular heart disease
Not willing or qualified for Magnetic Resonance Imaging of the heart
Unable to provide informed consent
Pregnancy (Pregnancy test will be performed before study participation)
Patients with pacemaker or intracardiac defibrillator implanted