Effects of Fish Oil on Post Ablation Arrhythmias
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|ClinicalTrials.gov Identifier: NCT00791089|
Recruitment Status : Terminated (unable to secure funding and long term follow up)
First Posted : November 14, 2008
Results First Posted : May 5, 2017
Last Update Posted : September 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Drug: LOVAZA Omega 3-acid ethyl esters Drug: LOVAZA Other: placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect of Omega-3 Fatty Acids on Short and Long-Term Maintenance of Sinus Rhythm After Radiofrequency Catheter Ablation for Atrial Fibrillation|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||October 2011|
Experimental: Fish Oil, Ablation, Sinus Rhythm
Patients in the treatment arm will receive omega-3 fatty acids (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure.
Drug: LOVAZA Omega 3-acid ethyl esters
Treatment with omega-3 fatty acids (4g/day) for 4 weeks before and 3 months after radiofrequency catheter ablation for AF.
(EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure.
Placebo Comparator: placebo, Ablation, sinus rhythm
Patients in the control arm will not receive any omega-3 fatty acids. However they will receive placebo.
Control group will receive placebo before & after ablation.
- Number of Participants With Normal Sinus Rhythm (Freedom From Atrial Arrhythmias) [ Time Frame: 6 months ]Freedom from atrial arrhythmias at 6 months will be defined as absence of any atrial arrhythmias with or without antiarrhythmic drug (AAD) therapy as shown in the two lines
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): NCT00791089
|United States, Michigan|
|University of Michigan Cardiovascular Center|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Hakan Oral, MD||University of Michigan Hospital|