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 currently recruiting participants.

Verified by Virginia Commonwealth University, September 2008

Sponsors and Collaborators:	Virginia Commonwealth University AtriCure, Inc.
Information provided by:	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

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

MedlinePlus related topics: Arrhythmia

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	5000
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (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

Contacts

Contact: Vigneshwar Kasirajan, MD	804-828-2774	vkasirajan@mcvh-vcu.edu
Contact: Angel Medina, RN	804-628-0741	amedina@mcvh-vcu.edu

Locations

United States, Virginia
Virginia Commonwealth University	Recruiting
Richmond, Virginia, United States, 23298
Contact: Vigneshwar Kasirajan, MD 804-828-2774 vkasirajan@mcvh-vcu.edu
Contact: Angel Medina, RN 804-628-0741 amedina@mcvh-vcu.edu
Principal Investigator: Vigneshwar Kasirajan, MD

Sponsors and Collaborators

Virginia Commonwealth University

AtriCure, Inc.

Investigators

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

More Information

VCU Pauley Heart Center Atrial Fibrillation Program This link exits the ClinicalTrials.gov site

Responsible Party:	Virginia Commonwealth University ( Vigneshwar Kasirajan, MD )
Study ID Numbers:	STAR Outcomes
Study First Received:	September 4, 2008
Last Updated:	September 5, 2008
ClinicalTrials.gov Identifier:	NCT00747838
Health Authority:	United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:

Afib
Atrial Fibrillation
Maze
Mini-Maze

Study placed in the following topic categories:

Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009