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Non - Invasive Evaluation of the Left Atrium Anatomy and Function

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Echocardiography
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universitair Ziekenhuis Brussel

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Atrial fibrillation patients

Arm Description

Patients with atrial fibrillation who underwent cryoballoon ablation

Outcomes

Primary Outcome Measures

Atrial fibrillation recurrence
Predictors of atrial fibrillation recurrence after ablation

Secondary Outcome Measures

Full Information

First Posted
February 27, 2018
Last Updated
March 24, 2020
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT03551158
Brief Title
Non - Invasive Evaluation of the Left Atrium Anatomy and Function
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
November 28, 2017 (Actual)
Primary Completion Date
June 28, 2018 (Actual)
Study Completion Date
December 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atrial fibrillation patients
Arm Type
Other
Arm Description
Patients with atrial fibrillation who underwent cryoballoon ablation
Intervention Type
Diagnostic Test
Intervention Name(s)
Echocardiography
Other Intervention Name(s)
cardiac computed tomography, cardiac magnetic resonance
Intervention Description
Cardiac imaging for the assessment of the left atrium anatomy and function.
Primary Outcome Measure Information:
Title
Atrial fibrillation recurrence
Description
Predictors of atrial fibrillation recurrence after ablation
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Droogmans, Professor
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitair Ziekenhuis Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24291276
Citation
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Results Reference
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PubMed Identifier
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Citation
Garg J, Chaudhary R, Palaniswamy C, Shah N, Krishnamoorthy P, Bozorgnia B, Natale A. Cryoballoon versus Radiofrequency Ablation for Atrial Fibrillation: A Meta-analysis of 16 Clinical Trials. J Atr Fibrillation. 2016 Oct 31;9(3):1429. doi: 10.4022/jafib.1429. eCollection 2016 Oct-Nov.
Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Non - Invasive Evaluation of the Left Atrium Anatomy and Function

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