Pulmonary Vein Isolation Outcomes With Fish Oils (PUFA)

Expanded access is no longer available for this treatment.
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
First received: February 10, 2009
Last updated: March 22, 2016
Last verified: March 2016
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 Intervention
Atrial Fibrillation
Drug: Lovaza (Fish Oils)

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

Resource links provided by NLM:

Further study details as provided by St. Luke's-Roosevelt Hospital Center:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00841451

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
Principal Investigator: Suneet Mittal, MD St. Luke's-Roosevelt Hospital Center
  More Information

Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT00841451     History of Changes
Other Study ID Numbers: 06-123 
Study First Received: February 10, 2009
Last Updated: March 22, 2016
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 26, 2016