Effects of Fish Oil on Post Ablation Arrhythmias
Recruitment status was Recruiting
To determine if peri-operative treatment with omega-3 fatty acids is associated with a decrease in the incidence of early recurrences of atrial arrhythmias (within 30 days) and an improvement in probability of long-term maintenance of sinus rhythm after radiofrequency catheter ablation for Atrial Fibrillation.
Drug: LOVAZA Omega 3-acid ethyl esters
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Effect of Omega-3 Fatty Acids on Short and Long-Term Maintenance of Sinus Rhythm After Radiofrequency Catheter Ablation for Atrial Fibrillation|
- Freedom from atrial arrhythmias at 6 months will be defined as absence of any atrial arrhythmias without antiarrhythmic drug therapy. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||October 2010|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
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.
Other Names:Drug: LOVAZA
(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.
AF is the most prevalent arrhythmia, affecting >2 million Americans. Antiarrhythmic drug therapy often is ineffective to eliminate recurrent episodes of AF. In recent years radiofrequency catheter ablation has emerged as a highly effective treatment strategy in patients with paroxysmal and chronic AF.6, 7 However, AF may recur within days to weeks after a successful ablation procedure in up to 50% of the patients, probably because of an inflammatory response to thermal injury caused by radiofrequency energy application. These early recurrences of AF after ablation do not necessarily predict long-term clinical outcome and 30-50% of patients who develop early recurrences ultimately remain in sinus rhythm without the need for additional ablation.8 However, early recurrences of AF may be associated with significant morbidity due to troubling symptoms of rapid ventricular rates, multiple hospital visits and cardioversions, need for antiarrhythmic drug therapy and prolongation in duration of anticoagulant therapy. It is also possible that if early recurrences of AF after ablation can be avoided, the probability of remaining in sinus rhythm during long-term follow-up may be higher, as maintenance of sinus rhythm early-on may facilitate reverse left atrial remodeling. A similar phenomenon may occur in post-operative AF, that develops in ~30% of patients who undergo cardiac surgery. Post-operative AF is often transient and usually resolves within 3 months after the surgery. Perioperative treatment with omega-3 fatty acids has been reported to decrease the incidence of postoperative AF after coronary artery by-pass surgery.4 Because the pathogenetic factors that play a role in postoperative AF and early recurrences of AF after radiofrequency catheter ablation may be similar, it is plausible that treatment with omega-3 fatty acids before and after ablation will be associated with a reduction in the incidence of early recurrences of AF.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00791089
|Contact: Jacqueline J Fortino, RN /BSNfirstname.lastname@example.org|
|United States, Michigan|
|University of Michigan Cardiovascular Center||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Jacqueline Fortino, RN / BSN 734-615-2680 email@example.com|
|Principal Investigator:||Hakan Oral, MD||University of Michigan Hospital|