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

      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
    • Barcelona
      • Madrid, Barcelona, Spain
        • Hospital Gregorio Marañón

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.

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

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.

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