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

This study has been terminated.
(Low enrollment.)
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00747838
First received: September 4, 2008
Last updated: May 24, 2013
Last verified: May 2013
  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:


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 ]

Enrollment: 106
Study Start Date: September 2008
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Minimally Invasive Maze Procedure
    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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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: May 24, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 25, 2014