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 (CHAZESubstrate)

November 16, 2021 updated by: University Hospital, Basel, Switzerland
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Cardiology/Electrophysiology, University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing catheter ablation for atrial fibrillation at the University Hospital Basel

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
single time point assessment at baseline
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
single time point assessment at baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 [%].
single time point assessment at baseline
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 [%].
single time point assessment at baseline
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)
single time point assessment at baseline
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)
single time point assessment at baseline
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)
single time point assessment at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Boston Scientific Corporation

Investigators

  • Principal Investigator: Michael Kuehne, Prof. Dr., Cardiology/Electrophysiology, University Hospital Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2019

Primary Completion (Actual)

May 31, 2021

Study Completion (Actual)

May 31, 2021

Study Registration Dates

First Submitted

September 17, 2019

First Submitted That Met QC Criteria

September 17, 2019

First Posted (Actual)

September 19, 2019

Study Record Updates

Last Update Posted (Actual)

November 17, 2021

Last Update Submitted That Met QC Criteria

November 16, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-01196; me19Kuehne2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Fibrillation (AF)

Clinical Trials on multipolar mapping catheter

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe