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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

NCT ID: NCT04095559

Last Updated: 2021-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-05

Study Completion Date

2021-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Atrial Fibrillation (AF)

Keywords

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left atrial (LA) substrate-based ablation focal ablation catheter bipolar voltage amplitude micro-electrode catheter IntellaMap Orion IntellaNav MIFI OI bipolar voltage maps irrigated-tip ablation catheter ring-electrode circular mapping catheter microelectrode multipolar catheter

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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multipolar mapping catheter

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

Intervention Type DIAGNOSTIC_TEST

multielectrode circular catheter

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

Intervention Type DIAGNOSTIC_TEST

irrigated ablation catheter

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Kuehne, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Cardiology/Electrophysiology, University Hospital Basel

Locations

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Cardiology/Electrophysiology, University Hospital Basel

Basel, , Switzerland

Site Status

Countries

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Switzerland

References

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Schlageter V, Luca A, Badertscher P, Krisai P, Kueffer T, Spreen D, Katic J, Osswald S, Schaer B, Sticherling C, Kuhne M, Knecht S. Effect of electrode size and distance to tissue on unipolar and bipolar voltage electrograms and their implications for a near-field cutoff. Sci Rep. 2024 Nov 8;14(1):27184. doi: 10.1038/s41598-024-78627-5.

Reference Type DERIVED
PMID: 39516302 (View on PubMed)

Other Identifiers

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2019-01196; me19Kuehne2

Identifier Type: -

Identifier Source: org_study_id