Non-invasive Substrate Evaluation in Atrial Fibrillation

C14.280.067.198 Clinical Trial

— NOISE-AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04496336
• Other study ID #: NOISE-AF
• Status: Completed
• Start date: February 20, 2020
• Est. completion date: November 20, 2022

Study information

• Verified date: March 2023
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The results will also be compared when the patient is in sinus rhythm and atrial fibrillation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 20, 2022
• Est. primary completion date: October 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• C14.280.067.198

Locations

Country	Name	City	State
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Gregorio Marañon	Madrid	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Gregorio Marañón Hospital

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline
Secondary	Correlation between voltage and MRI fibrosis.	The voltage in sinus rhythm and in atrial fibrillation will be correlated with the MRI-LGE.	Baseline
Secondary	Correlation between electrocardiographic image (ECGi) and MRI-LGE.	The xxx of the ECGi will be correlated with the MRI-LGE.	Baseline