search
Back to results

Effects of Fish Oil on Post Ablation Arrhythmias

Primary Purpose

Atrial Fibrillation

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
LOVAZA Omega 3-acid ethyl esters
LOVAZA
placebo
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Radiofrequency Ablation, atrial fibrillation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan Cardiovascular Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fish Oil, Ablation, Sinus Rhythm

placebo, Ablation, sinus rhythm

Arm Description

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.

Patients in the control arm will not receive any omega-3 fatty acids. However they will receive placebo.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 13, 2008
Last Updated
August 10, 2017
Sponsor
University of Michigan
Collaborators
GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT00791089
Brief Title
Effects of Fish Oil on Post Ablation Arrhythmias
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 Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
unable to secure funding and long term follow up
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Radiofrequency Ablation, atrial fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fish Oil, Ablation, Sinus Rhythm
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo, Ablation, sinus rhythm
Arm Type
Placebo Comparator
Arm Description
Patients in the control arm will not receive any omega-3 fatty acids. However they will receive placebo.
Intervention Type
Drug
Intervention Name(s)
LOVAZA Omega 3-acid ethyl esters
Other Intervention Name(s)
Fish Oil, Lovaza
Intervention Description
Treatment with omega-3 fatty acids (4g/day) for 4 weeks before and 3 months after radiofrequency catheter ablation for AF.
Intervention Type
Drug
Intervention Name(s)
LOVAZA
Intervention Description
(EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure.
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Control group will receive placebo before & after ablation.
Primary Outcome Measure Information:
Title
Number of Participants With Normal Sinus Rhythm (Freedom From Atrial Arrhythmias)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hakan Oral, MD
Organizational Affiliation
University of Michigan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Cardiovascular Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effects of Fish Oil on Post Ablation Arrhythmias

We'll reach out to this number within 24 hrs