Atrial Fibrillation
Conditions
Keywords
Radiofrequency Ablation, atrial fibrillation
Brief summary
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.
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.
Interventions
DRUGLOVAZA 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.
DRUGLOVAZA
(EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure.
OTHERplacebo
Control group will receive placebo before & after ablation.
Sponsors
GlaxoSmithKline
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Normal Sinus Rhythm (Freedom From Atrial Arrhythmias) | 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 |
Countries
United States
Participant flow
Pre-assignment details
All of the 12 participants were assigned to an intervention, but none completed all aspects of the study, because of study termination due to funding withdrawal. Still, basic baseline and outcome measure data was available for 11 of the 12, as noted below.
Participants by arm
| Arm | Count |
|---|---|
| Fish Oil, Ablation 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.
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.
LOVAZA: (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure. | 6 |
| Placebo, Ablation, Sinus Rhythm Patients in the control arm will not receive any omega-3 fatty acids. However they will receive placebo.
placebo: Control group will receive placebo before & after ablation. | 5 |
| Total | 11 |
Baseline characteristics
| Characteristic | Fish Oil, Ablation | Placebo, Ablation, Sinus Rhythm | Total |
|---|---|---|---|
| Age, Continuous | 56 years | 48.8 years | 52.7 years |
| Region of Enrollment United States | 6 participants | 5 participants | 12 participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 6 Participants | 4 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 1 / 6 | 3 / 6 |
| serious Total, serious adverse events | 1 / 6 | 0 / 6 |
Outcome results
Primary
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
Time frame: 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fish Oil, Ablation | Number of Participants With Normal Sinus Rhythm (Freedom From Atrial Arrhythmias) | FREEDOM FROM ATRIAL ARRHYTHMIAS WITHOUT AAD | 1 Participants |
| Fish Oil, Ablation | Number of Participants With Normal Sinus Rhythm (Freedom From Atrial Arrhythmias) | FREEDOM FROM ATRIAL ARRHYTHMIAS WITH AAD | 3 Participants |
| Placebo, Ablation | Number of Participants With Normal Sinus Rhythm (Freedom From Atrial Arrhythmias) | FREEDOM FROM ATRIAL ARRHYTHMIAS WITHOUT AAD | 2 Participants |
| Placebo, Ablation | Number of Participants With Normal Sinus Rhythm (Freedom From Atrial Arrhythmias) | FREEDOM FROM ATRIAL ARRHYTHMIAS WITH AAD | 1 Participants |