- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04496336
Non-invasive Substrate Evaluation in Atrial Fibrillation (NOISE-AF)
March 3, 2023 updated by: Josep Lluis Mont Girbau, Hospital Clinic of Barcelona
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
52
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
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Barcelona, Spain, 08036
- Hospital Clinic de Barcelona
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Barcelona
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Madrid, Barcelona, Spain
- Hospital Gregorio Marañón
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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 to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with persistent or paroxysmal atrial fibrillation, without cardiomyopathy (LVEF> 40%) or significant valvulopathy who will undergo first AF ablation.
Description
Inclusion Criteria:
- Atrial fibrillation paroxysmal or persistent with criteria for percutaneous ablation
Exclusion Criteria:
- Cardiomiopathy (FEVI<40%) or significant valvulopathy.
- MRI not possible or contraindicated.
- Previous atrial fibrillation ablation.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between voltage and MRI fibrosis.
Time Frame: Baseline
|
The voltage in sinus rhythm and in atrial fibrillation will be correlated with the MRI-LGE.
|
Baseline
|
Correlation between electrocardiographic image (ECGi) and MRI-LGE.
Time Frame: Baseline
|
The xxx of the ECGi will be correlated with the MRI-LGE.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
February 20, 2020
Primary Completion (Actual)
October 20, 2022
Study Completion (Actual)
November 20, 2022
Study Registration Dates
First Submitted
July 29, 2020
First Submitted That Met QC Criteria
July 29, 2020
First Posted (Actual)
August 3, 2020
Study Record Updates
Last Update Posted (Estimate)
March 6, 2023
Last Update Submitted That Met QC Criteria
March 3, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NOISE-AF
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.