NCT04095559

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

December 5, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

November 17, 2021

Status Verified

November 1, 2021

Enrollment Period

1.5 years

First QC Date

September 17, 2019

Last Update Submit

November 16, 2021

Conditions

Atrial Fibrillation (AF)

Keywords

left atrial (LA) substrate-based ablationfocal ablation catheterbipolar voltage amplitudemicro-electrode catheterIntellaMap OrionIntellaNav MIFI OIbipolar voltage mapsirrigated-tip ablation catheterring-electrode circular mapping cathetermicroelectrode multipolar catheter

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (5)

  • 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 [%].

    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)

    single time point assessment at baseline

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

    single time point assessment at baseline

Interventions

multipolar mapping catheterDIAGNOSTIC_TEST

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

multielectrode circular catheterDIAGNOSTIC_TEST

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

irrigated ablation catheterDIAGNOSTIC_TEST

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Documented atrial fibrillation
  • First or repeat catheter ablation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology/Electrophysiology, University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 39516302DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Kuehne, Prof. Dr.

    Cardiology/Electrophysiology, University Hospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2019

First Posted

September 19, 2019

Study Start

December 5, 2019

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

November 17, 2021

Record last verified: 2021-11

Locations

CH(1)