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NCT02801175 Clinical Trial

Effect of Left Atrial Ablation on Left Atrial Appendage Emptying Flow Velocity

Atrial Fibrillation Clinical Trial

— ABLAA-FV  

Official title:
Differential Effect of Radiofrequency and Cryoballoon Ablation on Left Atrial Appendage Emptying Flow Velocity

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02801175
Other study ID # 1/13.6.2016
Secondary ID
Status Recruiting
Phase N/A
First received June 13, 2016
Last updated June 13, 2016
Start date May 2016
Est. completion date March 2017

Study information
Verified date June 2016
Source National and Kapodistrian University of Athens
Contact Spyridon Deftereos, MD
Phone 2105832352
Email spdeftereos@med.uoa.gr
Is FDA regulated No
Health authority Greece: Ethics Committee
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date March 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 21 Years to 85 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Pulmonary vein isolation

Locations
Country Name City State
Greece 2nd Dept. of Cardiology, Univ of Athens Med Sch Athens

Sponsors (2)
Lead Sponsor Collaborator
National and Kapodistrian University of Athens G.Gennimatas General Hospital

Country where clinical trial is conducted

Greece, 

Outcome
Type Measure Description Time frame Safety issue
Primary LAA-EFV Left atrial appendage emptying flow velocity 1 month No
Secondary LAA-EFV Left atrial appendage emptying flow velocity 3 months No
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