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Effect of Left Atrial Ablation on Left Atrial Appendage Emptying Flow Velocity (ABLAA-FV)

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ClinicalTrials.gov Identifier: NCT02801175
Recruitment Status : Unknown
Verified June 2016 by Spyridon Deftereos, National and Kapodistrian University of Athens.
Recruitment status was:  Recruiting
First Posted : June 15, 2016
Last Update Posted : June 15, 2016
Sponsor:
Collaborator:
G.Gennimatas General Hospital
Information provided by (Responsible Party):
Spyridon Deftereos, National and Kapodistrian University of Athens

Brief Summary:
Consecutive patients with paroxysmal AFib scheduled to undergo pulmonary vein isolation either with radiofrequency (RF) or cryoballoon will be included. Left atrial appendage emptying flow velocity (LAA-EFV) will be measured with transesophageal echocardiography (TEE) immediately before and following left atrial ablation (1 month post). The change in LAA-EFV will be compared between the two groups (RF versus Cryo).

Condition or disease Intervention/treatment
Atrial Fibrillation Procedure: Pulmonary vein isolation

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Differential Effect of Radiofrequency and Cryoballoon Ablation on Left Atrial Appendage Emptying Flow Velocity
Study Start Date : May 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
RF
Patients with paroxysmal atrial fibrillation slated for radiofrequency pulmonary vein isolation
Procedure: Pulmonary vein isolation
Cryoballoon
Patients with paroxysmal atrial fibrillation slated for cryoballoon pulmonary vein isolation
Procedure: Pulmonary vein isolation



Primary Outcome Measures :
  1. LAA-EFV [ Time Frame: 1 month ]
    Left atrial appendage emptying flow velocity


Secondary Outcome Measures :
  1. LAA-EFV [ Time Frame: 3 months ]
    Left atrial appendage emptying flow velocity



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Ablation-naive patients with paroxysmal AFib
Criteria

Inclusion Criteria:

Paroxysmal atrial fibrillation, no absolute contraindication for anticoagulation

Exclusion Criteria:

Previous cardiac surgery Previous left atrial ablation History of cerebrovascular event Presence of LAA thrombus Inability to provide informed consent


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): NCT02801175


Contacts
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Contact: Spyridon Deftereos, MD 2105832352 spdeftereos@med.uoa.gr

Locations
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Greece
2nd Dept. of Cardiology, Univ of Athens Med Sch Recruiting
Athens, Greece, 12461
Contact: Spyridon Deftereos, MD    2105832352    spdeftereos@med.uoa.gr   
Sponsors and Collaborators
National and Kapodistrian University of Athens
G.Gennimatas General Hospital
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Responsible Party: Spyridon Deftereos, Associate Professor of Cardiology, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT02801175    
Other Study ID Numbers: 1/13.6.2016
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes