Pulmonary Vein Isolation Outcomes With Fish Oils | NCT00841451

Studies
Pulmonary Vein Isolation Outcomes With Fish Oils

NCT00841451

Sponsor

St. Luke's-Roosevelt Hospital Center

Status

No longer available

Last Update Posted

Mar 23, 2016Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Lovaza (Fish Oils)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

No longer available

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Feb 10, 2009

First Submission Date that Met QC Criteria

Feb 10, 2009

First Posted Date

Feb 11, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2016

Last Update Posted Date

Mar 23, 2016Estimated

Name	Class
GlaxoSmithKline	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Expanded Access

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Lovaza (Fish Oils)	Drug	Double blinded placebo controlled		Lovaza NDA021654 Omacor NDA021853

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Suneet Mittal, MD	St. Luke's-Roosevelt Hospital Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Valley Hospital		Ridgewood	New Jersey	07450	United States
University Medical Practice Associates 425 West 59th St. #9C

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D009821	Oils
D008055	Lipids