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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date June 13, 2016
First Posted Date June 15, 2016
Last Update Posted Date June 15, 2016
Study Start Date May 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 13, 2016)
LAA-EFV [ Time Frame: 1 month ]
Left atrial appendage emptying flow velocity
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 13, 2016)
LAA-EFV [ Time Frame: 3 months ]
Left atrial appendage emptying flow velocity
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of Left Atrial Ablation on Left Atrial Appendage Emptying Flow Velocity
Official Title Differential Effect of Radiofrequency and Cryoballoon Ablation on Left Atrial Appendage Emptying Flow Velocity
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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Ablation-naive patients with paroxysmal AFib
Condition Atrial Fibrillation
Intervention Procedure: Pulmonary vein isolation
Study Groups/Cohorts
  • RF
    Patients with paroxysmal atrial fibrillation slated for radiofrequency pulmonary vein isolation
    Intervention: Procedure: Pulmonary vein isolation
  • Cryoballoon
    Patients with paroxysmal atrial fibrillation slated for cryoballoon pulmonary vein isolation
    Intervention: Procedure: Pulmonary vein isolation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 13, 2016)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2017
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Greece
Removed Location Countries  
 
Administrative Information
NCT Number NCT02801175
Other Study ID Numbers 1/13.6.2016
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Spyridon Deftereos, National and Kapodistrian University of Athens
Study Sponsor National and Kapodistrian University of Athens
Collaborators G.Gennimatas General Hospital
Investigators Not Provided
PRS Account National and Kapodistrian University of Athens
Verification Date June 2016