Back to resultsPulmonary Vein Isolation Outcomes With Fish Oils (PUFA)
Primary Purpose
Atrial Fibrillation
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Lovaza (Fish Oils)
Sponsored by
About this trial
This is an expanded access trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Persistent, Paroxysmal, Pulmonary Vein isolation, Omega three fatty acids, Fish Oils
Eligibility Criteria
Inclusion Criteria:
- Paroxysmal Atrial fibrillation (PAF).
- Persistent atrial fibrillation. Persistent AF is not self-limited.
Exclusion Criteria:
- Previous pulmonary vein isolation ablation procedure
- Contraindication for anticoagulation
- Permanent AF
- Severe valvular pathology
- Concurrent use of antiarrhythmic medications
- Inability to give consent
- Pregnancy
Sites / Locations
- The Valley Hospital
- University Medical Practice Associates 425 West 59th St. #9C
- St.Luke's Hospital 1111 Amsterdam Ave. 3rd Floor Cardiology
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00841451
First Posted
February 10, 2009
Last Updated
March 22, 2016
Sponsor
St. Luke's-Roosevelt Hospital Center
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00841451
Brief Title
Pulmonary Vein Isolation Outcomes With Fish Oils
Acronym
PUFA
Official Title
Pulmonary Vein Isolation Outcomes With Eicosapentaenoic Acid (EPA)and Docosahexaenoic Acid (DHA)
Study Type
Expanded Access
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Luke's-Roosevelt Hospital Center
Collaborators
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
Fish oil therapy may decrease the incidence of cardiac arrhythmias. This study will test whether pre-treatment with fish oils before catheter ablation of atrial fibrillation decreases the early post operative occurrence of atrial fibrillation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation, Persistent, Paroxysmal, Pulmonary Vein isolation, Omega three fatty acids, Fish Oils
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lovaza (Fish Oils)
Other Intervention Name(s)
Lovaza NDA021654, Omacor NDA021853
Intervention Description
Double blinded placebo controlled
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
Paroxysmal Atrial fibrillation (PAF).
Persistent atrial fibrillation. Persistent AF is not self-limited.
Exclusion Criteria:
Previous pulmonary vein isolation ablation procedure
Contraindication for anticoagulation
Permanent AF
Severe valvular pathology
Concurrent use of antiarrhythmic medications
Inability to give consent
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suneet Mittal, MD
Organizational Affiliation
St. Luke's-Roosevelt Hospital Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
University Medical Practice Associates 425 West 59th St. #9C
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
St.Luke's Hospital 1111 Amsterdam Ave. 3rd Floor Cardiology
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pulmonary Vein Isolation Outcomes With Fish Oils
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