Atrial Fibrillation (AF)CHAZESubstrateNCT04095559
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
An observational study of Atrial Fibrillation (AF), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- multipolar mapping catheter, multielectrode circular catheter and irrigated ablation catheter
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Dec 2019to 31 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing catheter ablation for atrial fibrillation at the University Hospital Basel
Who may be able to join
- Documented atrial fibrillation
- First or repeat catheter ablation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Cardiology/Electrophysiology, University Hospital Basel
Basel, 4031
About this study
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.
Read the 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.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- multipolar mapping catheter, multielectrode circular catheter, irrigated ablation catheter
- Keywords
- 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
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
Global bipolar and unipolar signal measured in millivolt (mV)
Global bipolar and unipolar signal for the different types of catheters measured in mV
Measured: 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
Measured: single time point assessment at baseline
Secondary outcomes (5)
Global fibrosis content and distribution from LGE-MRI measured in [%].
Global fibrosis content and distribution from LGE-MRI measured in [%].
Measured: single time point assessment at baseline
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 [%].
Measured: single time point assessment at baseline
Differences of bipolar voltage characteristics between nearfield and farfield signals: amplitude (mV)
Differences of bipolar voltage characteristics between nearfield and farfield signals: amplitude (mV)
Measured: single time point assessment at baseline
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)
Measured: single time point assessment at baseline
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)
Measured: single time point assessment at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start5 Dec 2019
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Michael Kuehne, Prof. Dr., Principal investigator, Cardiology/Electrophysiology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095559
- Sponsor's protocol ID
- 2019-01196; me19Kuehne2
- Other IDs
- 2019
- Acronym
- CHAZESubstrate
- Status last verified
- Nov 2021
- First submitted
- 17 Sep 2019
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39516302
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04095559
- Acronym / sponsor ID
- CHAZESubstrate / 2019-01196; me19Kuehne2
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing catheter ablation for atrial fibrillation at the University Hospital Basel
Key inclusion criteria (2 listed)
- Documented atrial fibrillation
- First or repeat catheter ablation
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multipolar mapping cathetermapping of the left atrium will be performed in sinus rhythm using the IntellaMap Orion multipolar mapping catheter (Boston Scientific). | Diagnostic test | – |
| multielectrode circular cathetermapping of the left atrium will be performed using the multielectrode circular catheter (Lasso, spacing 2-6-2 mm, Biosense Webster) | Diagnostic test | – |
| irrigated ablation cathetermapping of the left atrium will be performed using the irrigated ablation catheter (IntellaNav Mifi OI) | Diagnostic test | – |
Primary outcome
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
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
5 secondary outcomes
Global fibrosis content and distribution from LGE-MRI measured in [%].
Time frame: 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
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: frequency in Hertz (Hz)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Derived from this study: PubMed 39516302Schlageter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kuehne, Prof. Dr. principal investigator
Cardiology/Electrophysiology, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global bipolar and unipolar signal measured in millivolt (mV) (time frame: single time point assessment at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04095559, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.