C14.280.067.198NOISE-AFNCT04496336
Non-invasive Substrate Evaluation in Atrial Fibrillation
An observational study of C14.280.067.198, run by Hospital Clinic of Barcelona at 2 sites in Spain.
Trial summary
The study aims to assess the right and left atrial electrophysiological substrate in atrial fibrillation patients using the invasive electroanatomic map (basal and with extraestimulus) as well as its correlation with cardiac magnetic resonance and electrocardiographic imaging. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- C14.280.067.198
- How many people
- 52 participants
- Where
- 2 sitesSpain
- Study dates
- 20 Feb 2020to 20 Nov 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with persistent or paroxysmal atrial fibrillation, without cardiomyopathy (LVEF> 40%) or significant valvulopathy who will undergo first AF ablation.
Who may be able to join
- Atrial fibrillation paroxysmal or persistent with criteria for percutaneous ablation
Who cannot join
- Cardiomiopathy (FEVI<40%) or significant valvulopathy.
- MRI not possible or contraindicated.
- Previous atrial fibrillation ablation.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Gregorio Marañon
Madrid, Barcelona
About this study
Official title: Non-invasive Substrate Evaluation in Atrial Fibrillation Using Cardiac Magnetic Resonance and Electrocardiographic Imaging
The study aims to assess the right and left atrial electrophysiological substrate in atrial fibrillation patients using the invasive electroanatomic map (basal and with extraestimulus) as well as its correlation with cardiac magnetic resonance and electrocardiographic imaging. The results will also be compared when the patient is in sinus rhythm and atrial fibrillation.
- Conditions
- C14.280.067.198
- Keywords
- Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between conduction velocity and MRI fibrosis.
The conduction velocity in sinusal rhythm and with extra estimuli will be correlated with the MRI late gadolinium enhancement sequence (MRI-LGE).
Measured: Baseline
Secondary outcomes (2)
Correlation between voltage and MRI fibrosis.
The voltage in sinus rhythm and in atrial fibrillation will be correlated with the MRI-LGE.
Measured: Baseline
Correlation between electrocardiographic image (ECGi) and MRI-LGE.
The xxx of the ECGi will be correlated with the MRI-LGE.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start20 Feb 2020
- Primary completion20 Oct 2022
- Study completion20 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C14.280.067.198Studies of the same condition, open and under way.
- 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Gregorio Marañón Hospital
- Responsible party
- Principal investigator, Josep Lluis Mont Girbau, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496336
- Sponsor's protocol ID
- NOISE-AF
- Acronym
- NOISE-AF
- Status last verified
- Mar 2023
- First submitted
- 29 Jul 2020
- Last updated
- 6 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Substrate Evaluation in Atrial Fibrillation Using Cardiac Magnetic Resonance and Electrocardiographic Imaging
- ClinicalTrials.gov ID
- NCT04496336
- Acronym / sponsor ID
- NOISE-AF / NOISE-AF
- Conditions
- C14.280.067.198
- Keywords
- Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Gregorio Marañón Hospital
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 20 Nov 2022 (actual)
- First posted
- 3 Aug 2020 (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.
The study aims to assess the right and left atrial electrophysiological substrate in atrial fibrillation patients using the invasive electroanatomic map (basal and with extraestimulus) as well as its correlation with cardiac magnetic resonance and electrocardiographic imaging. The results will also be compared when the patient is in sinus rhythm and atrial fibrillation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with persistent or paroxysmal atrial fibrillation, without cardiomyopathy (LVEF> 40%) or significant valvulopathy who will undergo first AF ablation.
Key inclusion criteria (1 listed)
- Atrial fibrillation paroxysmal or persistent with criteria for percutaneous ablation
Key exclusion criteria (3 listed)
- Cardiomiopathy (FEVI<40%) or significant valvulopathy.
- MRI not possible or contraindicated.
- Previous atrial fibrillation ablation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between conduction velocity and MRI fibrosis.
Time frame: Baseline
The conduction velocity in sinusal rhythm and with extra estimuli will be correlated with the MRI late gadolinium enhancement sequence (MRI-LGE).
2 secondary outcomes
Correlation between voltage and MRI fibrosis.
Time frame: Baseline
Correlation between electrocardiographic image (ECGi) and MRI-LGE.
Time frame: 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 6 Mar 2023.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of C14.280.067.198, run by Hospital Clinic of Barcelona at 2 sites 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 1 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: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Correlation between conduction velocity and MRI fibrosis. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2023.