Atrial Fibrillation and FlutterNCT05159180
Development of a New Impedance Mapping System for Ablation of Atrial Arrhythmias in Patients
An observational study of Atrial Fibrillation and Flutter and Atrial Arrhythmia, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Precise identification of the atrial fibrosis is essential for successful catheter ablation of atrial arrhythmias in patients with atrial fibrillation. Voltage mapping of endocardial electrograms is currently used to delineate the anatomical substrate, but this is influenced by the direction of the activation wave… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation and Flutter, Atrial Arrhythmia, Atrial Fibrillation Recurrent
- What is being tested?
- cardioz mapping
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 13 Dec 2021to 31 Dec 2022
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with atrial arrhythmias undergoing catheter ablation
Who may be able to join
- Age between 18 and 85 years.
- That they understand and sign the informed consent.
- That they do not present any contraindication.- Pass the exploration and tests prior to bioimpedance measurements.
Who cannot join
- Age outside the range described in the inclusion criteria.
- Subjects who present any type of complication during the procedure.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Gerard Amorós, MSc, PhD contact
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08026
Laia Angli, +34935537058, langli@santpau.cat
About this study
Official title: Desarrollo de un Nuevo Sistema de Mapeo de Impedancia Para la ablación de Las Arritmias Auriculares en Pacientes
Precise identification of the atrial fibrosis is essential for successful catheter ablation of atrial arrhythmias in patients with atrial fibrillation. Voltage mapping of endocardial electrograms is currently used to delineate the anatomical substrate, but this is influenced by the direction of the activation wave front and is limited by the patient-specific thresholds. Mapping of local myocardial electrical impedance may overcome these limitations.
Read the detailed description
Clinical series: Patients with atrial arrythmias undergoing catheter ablation of these will be submitted to mapping of both voltage and tissue impedance. Likewise, the accuracy of the two maps identifying the extent of the substrate will be assesssed by gadolinium imaging. The impedance system is already constructed and certified for clinical research use.
- Being tested
- cardioz mapping
- Keywords
- impedance spectroscopy, phase angle, impedance magnitude, Electroanatomical mapping
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardioz mappingDevice
Patients will be submitted to mapping of both voltage and tissue impedance.
| Study group | Role | What they receive |
|---|---|---|
| patients with atrial arrhythmias undergoing catheter ablation of these | Patients will be submitted to mapping of both voltage and tissue impedance. The accuracy of the two maps identifying the extent and transmurality of the infarction will be assesssed by gadolinium imaging. Receives: Device: cardioz mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparative detection of atrial scar by voltage mapping
Voltage will be measured at different sites of the atrial scar and healthy tissue.
Measured: 30 minutes
Comparative detection of atrial scar by impedance mapping
Myocardial local impedance spectroscopy will be measured at different sites of the atrial scar and healthy tissue.
Measured: 30 minutes
Comparative detection of atrial scar by gadolinium enhanced MR imaging
Intensity of gadolinium will be measured at different sites of the infarct scar and healthy tissue
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start13 Dec 2021 (estimated)
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation and FlutterStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159180
- Sponsor's protocol ID
- IIBSP-IMS-2021-74
- Status last verified
- Dec 2021
- First submitted
- 3 Dec 2021
- Last updated
- 20 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Amoros-Figueras G, Jorge E, Garcia-Sanchez T, Bragos R, Rosell-Ferrer J, Cinca J. Recognition of Fibrotic Infarct Density by the Pattern of Local Systolic-Diastolic Myocardial Electrical Impedance. Front Physiol. 2016 Aug 31;7:389. doi: 10.3389/fphys.2016.00389. eCollection 2016.
PubMed 27630580Amoros-Figueras G, Jorge E, Alonso-Martin C, Traver D, Ballesta M, Bragos R, Rosell-Ferrer J, Cinca J. Endocardial infarct scar recognition by myocardial electrical impedance is not influenced by changes in cardiac activation sequence. Heart Rhythm. 2018 Apr;15(4):589-596. doi: 10.1016/j.hrthm.2017.11.031. Epub 2017 Dec 27.
PubMed 29197656Jorge E, Amoros-Figueras G, Garcia-Sanchez T, Bragos R, Rosell-Ferrer J, Cinca J. Early detection of acute transmural myocardial ischemia by the phasic systolic-diastolic changes of local tissue electrical impedance. Am J Physiol Heart Circ Physiol. 2016 Feb 1;310(3):H436-43. doi: 10.1152/ajpheart.00754.2015. Epub 2015 Nov 25.
PubMed 26608340Amoros-Figueras G, Moreno-Weidmann Z, Mendez-Zurita F, Soriano-Amores M, Bragos R, Rosell-Ferrer J, Guerra JM. Local multifrequency impedance changes after radiofrequency ablation in human atria: potential use for tissue characterization. Front Cardiovasc Med. 2025 Oct 7;12:1668533. doi: 10.3389/fcvm.2025.1668533. eCollection 2025.
PubMed 41126919
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Desarrollo de un Nuevo Sistema de Mapeo de Impedancia Para la ablación de Las Arritmias Auriculares en Pacientes
- ClinicalTrials.gov ID
- NCT05159180
- Acronym / sponsor ID
- IIBSP-IMS-2021-74
- Keywords
- impedance spectroscopy, phase angle, impedance magnitude, Electroanatomical mapping
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 13 Dec 2021 (estimated)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 16 Dec 2021 (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.
Precise identification of the atrial fibrosis is essential for successful catheter ablation of atrial arrhythmias in patients with atrial fibrillation. Voltage mapping of endocardial electrograms is currently used to delineate the anatomical substrate, but this is influenced by the direction of the activation wave front and is limited by the patient-specific thresholds. Mapping of local myocardial electrical impedance may overcome these limitations.
Detailed description
Clinical series: Patients with atrial arrythmias undergoing catheter ablation of these will be submitted to mapping of both voltage and tissue impedance. Likewise, the accuracy of the two maps identifying the extent of the substrate will be assesssed by gadolinium imaging. The impedance system is already constructed and certified for clinical research use.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with atrial arrhythmias undergoing catheter ablation of these | – | Device: cardioz mappingPatients will be submitted to mapping of both voltage and tissue impedance. The accuracy of the two maps identifying the extent and transmurality of the infarction will be assesssed by gadolinium imaging. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with atrial arrhythmias undergoing catheter ablation
Key inclusion criteria (3 listed)
- Age between 18 and 85 years.
- That they understand and sign the informed consent.
- That they do not present any contraindication.- Pass the exploration and tests prior to bioimpedance measurements.
Key exclusion criteria (3 listed)
- Age outside the range described in the inclusion criteria.
- Subjects who present any type of complication during the procedure.
- Pregnancy.
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 |
|---|---|---|
| cardioz mappingPatients will be submitted to mapping of both voltage and tissue impedance. | Device | patients with atrial arrhythmias undergoing catheter ablation of these |
Primary outcome
Comparative detection of atrial scar by voltage mapping
Time frame: 30 minutes
Voltage will be measured at different sites of the atrial scar and healthy tissue.
Comparative detection of atrial scar by impedance mapping
Time frame: 30 minutes
Myocardial local impedance spectroscopy will be measured at different sites of the atrial scar and healthy tissue.
Comparative detection of atrial scar by gadolinium enhanced MR imaging
Time frame: 30 minutes
Intensity of gadolinium will be measured at different sites of the infarct scar and healthy tissue
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
- Results publication: PubMed 27630580Amoros-Figueras G, Jorge E, Garcia-Sanchez T, Bragos R, Rosell-Ferrer J, Cinca J. Recognition of Fibrotic Infarct Density by the Pattern of Local Systolic-Diastolic Myocardial Electrical Impedance. Front Physiol. 2016 Aug 31;7:389. doi: 10.3389/fphys.2016.00389. eCollection 2016.
- Results publication: PubMed 29197656Amoros-Figueras G, Jorge E, Alonso-Martin C, Traver D, Ballesta M, Bragos R, Rosell-Ferrer J, Cinca J. Endocardial infarct scar recognition by myocardial electrical impedance is not influenced by changes in cardiac activation sequence. Heart Rhythm. 2018 Apr;15(4):589-596. doi: 10.1016/j.hrthm.2017.11.031. Epub 2017 Dec 27.
- Results publication: PubMed 26608340Jorge E, Amoros-Figueras G, Garcia-Sanchez T, Bragos R, Rosell-Ferrer J, Cinca J. Early detection of acute transmural myocardial ischemia by the phasic systolic-diastolic changes of local tissue electrical impedance. Am J Physiol Heart Circ Physiol. 2016 Feb 1;310(3):H436-43. doi: 10.1152/ajpheart.00754.2015. Epub 2015 Nov 25.
- Derived from this study: PubMed 41126919Amoros-Figueras G, Moreno-Weidmann Z, Mendez-Zurita F, Soriano-Amores M, Bragos R, Rosell-Ferrer J, Guerra JM. Local multifrequency impedance changes after radiofrequency ablation in human atria: potential use for tissue characterization. Front Cardiovasc Med. 2025 Oct 7;12:1668533. doi: 10.3389/fcvm.2025.1668533. eCollection 2025.
- Individual participant dataSharing planned: Undecided
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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.
Gerard Amorós, MSc, PhD contact
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 and Flutter and Atrial Arrhythmia, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Dec 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jose M Guerra, MD, PhD (+34935537058, jguerra@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparative detection of atrial scar by voltage mapping (time frame: 30 minutes). The study lists 3 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 NCT05159180, which also lists 4 linked publications.
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 20 Dec 2021.