A Multicenter Data Registry for Outcomes From Surgical Treatment of Atrial Arrhythmias - Full Text View

A Multicenter Data Registry for Outcomes From Surgical Treatment of Atrial Arrhythmias (STAR)

This study is ongoing, but not recruiting participants.

First Received on September 4, 2008. Last Updated on October 10, 2011 History of Changes

Sponsor:	Virginia Commonwealth University
Information provided by (Responsible Party):	Virginia Commonwealth University
ClinicalTrials.gov Identifier:	NCT00747838

Purpose

Minimally invasive surgical treatment of atrial fibrillation is safe and effective at controlling atrial fibrillation. The fundamental goal of STAR Outcomes registry is to improve the understanding of the efficacy of surgical ablation intervention in the treatment of atrial fibrillation.

Condition	Intervention
Atrial Fibrillation	Procedure: Minimally Invasive Maze Procedure

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Surgical Treatment for Atrial Arrhythmia Registry (STAR Outcomes)

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Arrhythmia Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:

Minimally invasive surgical treatment of atrial fibrillation is safe and effective at controlling atrial fibrillation [ Time Frame: One Year ] [ Designated as safety issue: No ]

Estimated Enrollment:	5000
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Intervention Details:

Minimally Invasive Surgical Correction of Atrial Fibrillation.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Adult patients with paroxysmal (intermittent) or persistent atrial fibrillation undergoing surgical correction.

Criteria

Inclusion Criteria:

Adult patients with paroxysmal (intermittent) or persistent atrial fibrillation
> 18 years of age

Exclusion Criteria:

Patients unable to give adequate informed consent
Patients who are known to be pregnant, plan to become pregnant or are lactating
Inability to return for follow up
Patients who are prison inmates or institutionalized
Patients in an emergency state
Patients under the age of 18

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747838

Locations

United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298

Sponsors and Collaborators

Virginia Commonwealth University

Investigators

Principal Investigator:	Vigneshwar Kasirajan, MD	Virginia Commonwealth University
Principal Investigator:	Kenneth Ellenbogen, MD	Virginia Commonwealth University

More Information

No publications provided by Virginia Commonwealth University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kron J, Kasirajan V, Wood MA, Kowalski M, Han FT, Ellenbogen KA. Management of recurrent atrial arrhythmias after minimally invasive surgical pulmonary vein isolation and ganglionic plexi ablation for atrial fibrillation. Heart Rhythm. 2010 Apr;7(4):445-51. Epub 2009 Dec 16.

Responsible Party:	Virginia Commonwealth University
ClinicalTrials.gov Identifier:	NCT00747838 History of Changes
Other Study ID Numbers:	STAR Outcomes
Study First Received:	September 4, 2008
Last Updated:	October 10, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:

Afib
Atrial Fibrillation
Maze
Mini-Maze

Additional relevant MeSH terms:

Arrhythmias, Cardiac
Atrial Fibrillation
Atrial Premature Complexes
Heart Diseases

Cardiovascular Diseases
Pathologic Processes
Cardiac Complexes, Premature

ClinicalTrials.gov processed this record on February 09, 2012