Pulmonary Vein Isolation Outcomes With Fish Oils (PUFA)
Expanded access is temporarily not available for this treatment.
Sponsor:
St. Luke's-Roosevelt Hospital Center
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
| Tracking Information | |||||
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| First Received Date ICMJE | February 10, 2009 | ||||
| Last Updated Date | October 15, 2012 | ||||
| Start Date ICMJE | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00841451 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Pulmonary Vein Isolation Outcomes With Fish Oils | ||||
| Official Title ICMJE | Pulmonary Vein Isolation Outcomes With Eicosapentaenoic Acid (EPA)and Docosahexaenoic Acid (DHA) | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Expanded Access | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Not Provided | ||||
| Condition ICMJE | Atrial Fibrillation | ||||
| Intervention ICMJE | Drug: Lovaza (Fish Oils)
Double blinded placebo controlled
Other Names:
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Temporarily not available | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00841451 | ||||
| Other Study ID Numbers ICMJE | 06-123 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | St. Luke's-Roosevelt Hospital Center | ||||
| Study Sponsor ICMJE | St. Luke's-Roosevelt Hospital Center | ||||
| Collaborators ICMJE | GlaxoSmithKline | ||||
| Investigators ICMJE |
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| Information Provided By | St. Luke's-Roosevelt Hospital Center | ||||
| Verification Date | June 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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