NCT04496336

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2020

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 3, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2022

Completed
Last Updated

March 6, 2023

Status Verified

March 1, 2023

Enrollment Period

2.7 years

First QC Date

July 29, 2020

Last Update Submit

March 3, 2023

Conditions

C14.280.067.198

Keywords

Atrial FibrillationParoxysmal Atrial FibrillationPersistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Correlation between voltage and MRI fibrosis.

    Baseline

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

    Baseline

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with persistent or paroxysmal atrial fibrillation, without cardiomyopathy (LVEF\> 40%) or significant valvulopathy who will undergo first AF ablation.

You may qualify if:

  • Atrial fibrillation paroxysmal or persistent with criteria for percutaneous ablation

You may not qualify if:

  • Cardiomiopathy (FEVI\<40%) or significant valvulopathy.
  • MRI not possible or contraindicated.
  • Previous atrial fibrillation ablation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Gregorio Marañon

Madrid, Barcelona, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Arrythmia Unit

Study Record Dates

First Submitted

July 29, 2020

First Posted

August 3, 2020

Study Start

February 20, 2020

Primary Completion

October 20, 2022

Study Completion

November 20, 2022

Last Updated

March 6, 2023

Record last verified: 2023-03

Locations

ES(2)