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Pulmonary Vein Isolation Outcomes With Fish Oils (PUFA)

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ClinicalTrials.gov Identifier: NCT00841451
Recruitment Status : No longer available
First Posted : February 11, 2009
Last Update Posted : March 23, 2016
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center

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.

Condition or disease Intervention/treatment
Atrial Fibrillation Drug: Lovaza (Fish Oils)

Study Type : Expanded Access
Official Title: Pulmonary Vein Isolation Outcomes With Eicosapentaenoic Acid (EPA)and Docosahexaenoic Acid (DHA)

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: Lovaza (Fish Oils)
    Double blinded placebo controlled
    Other Names:
    • Lovaza NDA021654
    • Omacor NDA021853

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00841451


Locations
United States, New Jersey
The Valley Hospital
Ridgewood, New Jersey, United States, 07450
United States, New York
University Medical Practice Associates 425 West 59th St. #9C
New York, New York, United States, 10019
St.Luke's Hospital 1111 Amsterdam Ave. 3rd Floor Cardiology
New York, New York, United States, 10025
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
GlaxoSmithKline
Investigators
Principal Investigator: Suneet Mittal, MD St. Luke's-Roosevelt Hospital Center

Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT00841451     History of Changes
Other Study ID Numbers: 06-123
First Posted: February 11, 2009    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: March 2016

Keywords provided by St. Luke's-Roosevelt Hospital Center:
Atrial Fibrillation
Persistent
Paroxysmal
Pulmonary Vein isolation
Omega three fatty acids
Fish Oils

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes