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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00747838
Recruitment Status : Terminated (Low enrollment.)
First Posted : September 5, 2008
Last Update Posted : May 27, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Atrial Fibrillation Procedure: Minimally Invasive Maze Procedure

Study Design

Study Type : Observational
Actual Enrollment : 106 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Surgical Treatment for Atrial Arrhythmia Registry (STAR Outcomes)
Study Start Date : September 2008
Primary Completion Date : September 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Procedure: Minimally Invasive Maze Procedure
    Minimally Invasive Surgical Correction of Atrial Fibrillation.

Outcome Measures

Primary Outcome Measures :
  1. Minimally invasive surgical treatment of atrial fibrillation is safe and effective at controlling atrial fibrillation [ Time Frame: One Year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:

  1. Adult patients with paroxysmal (intermittent) or persistent atrial fibrillation
  2. > 18 years of age

Exclusion Criteria:

  1. Patients unable to give adequate informed consent
  2. Patients who are known to be pregnant, plan to become pregnant or are lactating
  3. Inability to return for follow up
  4. Patients who are prison inmates or institutionalized
  5. Patients in an emergency state
  6. Patients under the age of 18
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00747838     History of Changes
Other Study ID Numbers: STAR Outcomes
First Posted: September 5, 2008    Key Record Dates
Last Update Posted: May 27, 2013
Last Verified: May 2013

Keywords provided by Virginia Commonwealth University:
Afib
Atrial Fibrillation
Maze
Mini-Maze

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes