Effects of Fish Oil on Post Ablation Arrhythmias

Effect of Omega-3 Fatty Acids on Short and Long-Term Maintenance of Sinus Rhythm After Radiofrequency Catheter Ablation for Atrial Fibrillation

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.

Study Overview

• Status: Terminated
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: LOVAZA Omega 3-acid ethyl esters; Drug: LOVAZA; Other: placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Cardiovascular Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age > 18 years and < 70 years old
• Left atrial size <55 mm

Exclusion Criteria:

• Inability or unwillingness to provide informed consent
• Current therapy with omega-3 fatty acids
• Current therapy with a statin
• Active liver disease
• Significant comorbidity such as end-stage renal disease or cirrhosis
• Valvular prosthesis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Lovaza; Fish Oil; 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.	Other: placebo; Control group will receive placebo before & after ablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Normal Sinus Rhythm (Freedom From Atrial Arrhythmias)	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	6 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: Hakan Oral, MD, University of Michigan Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: November 13, 2008
• First Submitted That Met QC Criteria: November 13, 2008
• First Posted (Estimate): November 14, 2008

Study Record Updates

• Last Update Posted (Actual): September 12, 2017
• Last Update Submitted That Met QC Criteria: August 10, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: atrial fibrillation; Radiofrequency Ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: LVZ111900