Non - Invasive Evaluation of the Left Atrium Anatomy and Function

March 24, 2020 updated by: Universitair Ziekenhuis Brussel

The Search for Non-invasive Determinants of Response to Ablation of Atrial Fibrillation. Non-invasive Evaluation of Left Atrium Anatomy and Function With Three Dimensional Echocardiography: Comparison With Cardiac CT and MRI

The aim of the study is to evaluate the accuracy and reproducibility of the left atrium (LA) anatomy and function in different populations and in patients with atrial fibrillation who have undergone cryoballoon ablation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study implies three parts. The first part of the study aims to evaluate the variability and reproducibility of rest two - and three-dimensional echocardiography for the left atrium anatomy and function and to assess their correlation with clinical variables.

The second part of the study aims to evaluate the accuracy and reproducibility of the left atrium anatomy and function using echocardiography and to validate it with cardiac CT. Moreover, the study aims to evaluate which parameters can predict the recurrence of atrial fibrillation in patients who have undergone atrial fibrillation ablation.

The third part of the study aims to assess the accuracy and variability of echocardiographic measurements compared to cardiac magnetic resonance and to find predictors of recurrence after cryoballoon ablation for atrial fibrillation.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

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

  • Belgium
      • Brussels, Belgium, 1090
        • Universitair Ziekenhuis Brussel

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • subsequent group of patients sent to the echocardiography laboratory for any indication/patients who have undergone a cryoballoon ablation
  • older than 18 years old

Exclusion Criteria:

• inadequate image quality during echocardiography, contraindications for computed tomography or cardiac magnetic resonance

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Atrial fibrillation patients
Patients with atrial fibrillation who underwent cryoballoon ablation
Diagnostic test: Echocardiography
Cardiac imaging for the assessment of the left atrium anatomy and function.
Other Names:
  • cardiac computed tomography
  • cardiac magnetic resonance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atrial fibrillation recurrence
Time Frame: 1 year
Predictors of atrial fibrillation recurrence after ablation
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Investigators

  • Principal Investigator: Steven Droogmans, Professor, Universitair Ziekenhuis Brussel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 28, 2017

Primary Completion (Actual)

June 28, 2018

Study Completion (Actual)

December 28, 2019

Study Registration Dates

First Submitted

February 27, 2018

First Submitted That Met QC Criteria

May 27, 2018

First Posted (Actual)

June 11, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/221

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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