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

Atrial Fibrillation (AF) Clinical Trial

— CHAZESubstrate  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04095559
• Other study ID #: 2019-01196; me19Kuehne2
• Status: Completed
• Start date: December 5, 2019
• Est. completion date: May 31, 2021

Study information

• Verified date: November 2021
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation (AF)

Intervention

Diagnostic Test:
• multipolar mapping catheter
mapping of the left atrium will be performed in sinus rhythm using the IntellaMap Orion multipolar mapping catheter (Boston Scientific).
• multielectrode circular catheter
mapping of the left atrium will be performed using the multielectrode circular catheter (Lasso, spacing 2-6-2 mm, Biosense Webster)
• irrigated ablation catheter
mapping of the left atrium will be performed using the irrigated ablation catheter (IntellaNav Mifi OI)

Locations

Country	Name	City	State
Switzerland	Cardiology/Electrophysiology, University Hospital Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Boston Scientific Corporation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global bipolar and unipolar signal measured in millivolt (mV)	Global bipolar and unipolar signal for the different types of catheters measured in mV	single time point assessment at baseline
Primary	Local bipolar and unipolar signal measured in mV	Local bipolar and unipolar signal for the different types of catheters measured in mV	single time point assessment at baseline
Secondary	Global fibrosis content and distribution from LGE-MRI measured in [%].	Global fibrosis content and distribution from LGE-MRI measured in [%].	single time point assessment at baseline
Secondary	Local fibrosis content and distribution from Late-gadolinium enhanced Magnetic Resonance Imaging (LGE-MRI) measured in [%].	Local fibrosis content and distribution from LGE-MRI measured in [%].	single time point assessment at baseline
Secondary	Differences of bipolar voltage characteristics between nearfield and farfield signals: amplitude (mV)	Differences of bipolar voltage characteristics between nearfield and farfield signals: amplitude (mV)	single time point assessment at baseline
Secondary	Differences of bipolar voltage characteristics between nearfield and farfield signals: frequency in Hertz (Hz)	Differences of bipolar voltage characteristics between nearfield and farfield signals: frequency (Hz)	single time point assessment at baseline
Secondary	Differences of bipolar voltage characteristics between nearfield and farfield signals: Duration in milliseconds (ms)	Differences of bipolar voltage characteristics between nearfield and farfield signals: duration (ms)	single time point assessment at baseline