- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02801175
Effect of Left Atrial Ablation on Left Atrial Appendage Emptying Flow Velocity (ABLAA-FV)
June 13, 2016 updated by: Spyridon Deftereos, National and Kapodistrian University of Athens
Differential Effect of Radiofrequency and Cryoballoon Ablation on Left Atrial Appendage Emptying Flow Velocity
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).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Spyridon Deftereos, MD
- Phone Number: 2105832352
- Email: spdeftereos@med.uoa.gr
Study Locations
-
-
-
Athens, Greece, 12461
- Recruiting
- 2nd Dept. of Cardiology, Univ of Athens Med Sch
-
Contact:
- Spyridon Deftereos, MD
- Phone Number: 2105832352
- Email: spdeftereos@med.uoa.gr
-
-
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
21 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Ablation-naive patients with paroxysmal AFib
Description
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 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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
RF
Patients with paroxysmal atrial fibrillation slated for radiofrequency pulmonary vein isolation
|
|
Cryoballoon
Patients with paroxysmal atrial fibrillation slated for cryoballoon pulmonary vein isolation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
LAA-EFV
Time Frame: 1 month
|
Left atrial appendage emptying flow velocity
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
LAA-EFV
Time Frame: 3 months
|
Left atrial appendage emptying flow velocity
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
May 1, 2016
Primary Completion (Anticipated)
December 1, 2016
Study Completion (Anticipated)
March 1, 2017
Study Registration Dates
First Submitted
June 13, 2016
First Submitted That Met QC Criteria
June 13, 2016
First Posted (Estimate)
June 15, 2016
Study Record Updates
Last Update Posted (Estimate)
June 15, 2016
Last Update Submitted That Met QC Criteria
June 13, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1/13.6.2016
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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