Not provided
Not provided
Not provided
Not provided
Not provided
unable to secure funding and long term follow up
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fish Oil, Ablation, Sinus Rhythm | Experimental | 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. |
|
| placebo, Ablation, sinus rhythm | Placebo Comparator | Patients in the control arm will not receive any omega-3 fatty acids. However they will receive placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LOVAZA Omega 3-acid ethyl esters | Drug | Treatment with omega-3 fatty acids (4g/day) for 4 weeks before and 3 months after radiofrequency catheter ablation for AF. |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hakan Oral, MD | University of Michigan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Cardiovascular Center | Ann Arbor | Michigan | 48109 | United States |
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline analysis is provided for all persons who actually began their assignment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | One age for one participant randomized to this arm is unavailable. This participant actually never began placebo. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 6 months |
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Tamponnade | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | Systematic Assessment |
The Study was terminated before subject enrollment completion, due to financial concerns and loss of major support from the 21-day cardiac monitoring device. So small sample size means data should be interpreted with great caution.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hakan Oral | University of Michigan | 734 936-6868 | oralh@med.umich.edu |
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D005395 | Fish Oils |
| C405603 | Omacor |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| LOVAZA | Drug | (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure. |
|
| placebo | Other | Control group will receive placebo before & after ablation. |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Full Range |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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. |
|
|
| 0 |
| 6 |
| 1 |
| 6 |
| 1 |
| 6 |
| EG001 | Placebo, Ablation | 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. | 0 | 6 | 0 | 6 | 3 | 6 |
| Fluid gain | Surgical and medical procedures | Systematic Assessment |
|
| Spot on Face | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Painful vericose veins | Blood and lymphatic system disorders | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | Systematic Assessment |
|
| pneumonitis | Surgical and medical procedures | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |