- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00747838
A Multicenter Data Registry for Outcomes From Surgical Treatment of Atrial Arrhythmias (STAR)
May 24, 2013 updated by: Virginia Commonwealth University
Surgical Treatment for Atrial Arrhythmia Registry (STAR Outcomes)
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
106
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Virginia
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Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult patients with paroxysmal (intermittent) or persistent atrial fibrillation undergoing surgical correction.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Minimally invasive surgical treatment of atrial fibrillation is safe and effective at controlling atrial fibrillation
Time Frame: One Year
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One Year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kenneth Ellenbogen, MD, Virginia Commonwealth University
- Principal Investigator: Vigneshwar Kasirajan, MD, Virginia Commonwealth University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Saini A, Hu YL, Kasirajan V, Han FT, Khan MZ, Wolfe L, Gunda S, Koneru JN, Ellenbogen KA. Long-term outcomes of minimally invasive surgical ablation for atrial fibrillation: A single-center experience. Heart Rhythm. 2017 Sep;14(9):1281-1288. doi: 10.1016/j.hrthm.2017.04.029. Epub 2017 Apr 22.
- Kasirajan V, Spradlin EA, Mormando TE, Medina AE, Ovadia P, Schwartzman DS, Gaines TE, Mumtaz MA, Downing SW, Ellenbogen KA. Minimally invasive surgery using bipolar radiofrequency energy is effective treatment for refractory atrial fibrillation. Ann Thorac Surg. 2012 May;93(5):1456-61. doi: 10.1016/j.athoracsur.2012.01.110.
- 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. doi: 10.1016/j.hrthm.2009.12.008. Epub 2009 Dec 16.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
September 4, 2008
First Submitted That Met QC Criteria
September 4, 2008
First Posted (Estimate)
September 5, 2008
Study Record Updates
Last Update Posted (Estimate)
May 27, 2013
Last Update Submitted That Met QC Criteria
May 24, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STAR Outcomes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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