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Completed

NCT Number: NCT04095559

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiology/Electrophysiology, University Hospital Basel

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multipolar mapping catheter

Diagnostic Test

mapping of the left atrium will be performed in sinus rhythm using the IntellaMap Orion multipolar mapping catheter (Boston Scientific).

multielectrode circular catheter

Diagnostic Test

mapping of the left atrium will be performed using the multielectrode circular catheter (Lasso, spacing 2-6-2 mm, Biosense Webster)

irrigated ablation catheter

Diagnostic Test

mapping of the left atrium will be performed using the irrigated ablation catheter (IntellaNav Mifi OI)

Primary outcomes

  1. Global bipolar and unipolar signal measured in millivolt (mV)

    Time frame: single time point assessment at baseline

    Global bipolar and unipolar signal for the different types of catheters measured in mV

  2. Local bipolar and unipolar signal measured in mV

    Time frame: single time point assessment at baseline

    Local bipolar and unipolar signal for the different types of catheters measured in mV

Secondary outcomes

  1. Global fibrosis content and distribution from LGE-MRI measured in [%].

    Time frame: single time point assessment at baseline

    Global fibrosis content and distribution from LGE-MRI measured in [%].

  2. Local fibrosis content and distribution from Late-gadolinium enhanced Magnetic Resonance Imaging (LGE-MRI) measured in [%].

    Time frame: single time point assessment at baseline

    Local fibrosis content and distribution from LGE-MRI measured in [%].

  3. Differences of bipolar voltage characteristics between nearfield and farfield signals: amplitude (mV)

    Time frame: single time point assessment at baseline

    Differences of bipolar voltage characteristics between nearfield and farfield signals: amplitude (mV)

  4. Differences of bipolar voltage characteristics between nearfield and farfield signals: frequency in Hertz (Hz)

    Time frame: single time point assessment at baseline

    Differences of bipolar voltage characteristics between nearfield and farfield signals: frequency (Hz)

  5. Differences of bipolar voltage characteristics between nearfield and farfield signals: Duration in milliseconds (ms)

    Time frame: single time point assessment at baseline

    Differences of bipolar voltage characteristics between nearfield and farfield signals: duration (ms)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Acronym: CHAZESubstrate

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 19, 2019
Registry last updated
Nov 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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