Text Size

Pulmonary Vein Isolation Outcomes With Fish Oils (PUFA)

Expanded access is temporarily not available for this treatment.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT00841451
First received: February 10, 2009
Last updated: October 15, 2012
Last verified: June 2011
History of Changes
  Purpose

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:

U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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: October 15, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 18, 2013