Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Non-invasive Substrate Evaluation in Atrial Fibrillation (NOISE-AF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04496336
Recruitment Status : Recruiting
First Posted : August 3, 2020
Last Update Posted : August 11, 2020
Sponsor:
Collaborator:
Gregorio Marañón Hospital
Information provided by (Responsible Party):
Josep Lluis Mont Girbau, Hospital Clinic of Barcelona

Brief 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.

Condition or disease
C14.280.067.198

Layout table for study information
Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-invasive Substrate Evaluation in Atrial Fibrillation Using Cardiac Magnetic Resonance and Electrocardiographic Imaging
Actual Study Start Date : February 20, 2020
Estimated Primary Completion Date : January 20, 2021
Estimated Study Completion Date : January 20, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04496336


Locations
Layout table for location information
Spain
Hospital Gregorio Marañon Recruiting
Madrid, Barcelona, Spain
Contact: Felipe Atienza, MD, PhD    +34915868286    felipeatienza@gmail.com   
Hospital Clinic de Barcelona Not yet recruiting
Barcelona, Spain, 08036
Contact: Lluis Mont, MD, PhD    +3493227551    lmont@clinic.ub.es   
Contact: Mont         
Principal Investigator: Lluis Mont, MD, PhD         
Sub-Investigator: Gala Caixal, MD         
Sub-Investigator: Eduard Guasch, MD, PhD         
Sub-Investigator: Roger Borras, BSc         
Sub-Investigator: Francisco Alarcón, B Eng         
Sub-Investigator: Paz Garre, B Eng         
Sub-Investigator: Ivo Roca, MD, PhD         
Sub-Investigator: Jose Maria Tolosana, MD, PhD         
Sponsors and Collaborators
Hospital Clinic of Barcelona
Gregorio Marañón Hospital
Layout table for additonal information
Responsible Party: Josep Lluis Mont Girbau, Head of Arrythmia Unit, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT04496336    
Other Study ID Numbers: NOISE-AF
First Posted: August 3, 2020    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Josep Lluis Mont Girbau, Hospital Clinic of Barcelona:
Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes