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OpenTrials
Completed

NCT Number: NCT04496336

Non-invasive Substrate Evaluation in Atrial Fibrillation

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.

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Key information

Conditions

C14.280.067.198 Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Gregorio Marañon, Madrid, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. Correlation between electrocardiographic image (ECGi) and MRI-LGE.

    Time frame: Baseline

    The xxx of the ECGi will be correlated with the MRI-LGE.

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • Gregorio Marañón Hospital

Registry information

Official study title

Non-invasive Substrate Evaluation in Atrial Fibrillation Using Cardiac Magnetic Resonance and Electrocardiographic Imaging

Acronym: NOISE-AF

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 3, 2020
Registry last updated
Mar 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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