A Multicenter Data Registry for Outcomes From Surgical Treatment of Atrial Arrhythmias (STAR)
This study is ongoing, but not recruiting participants.
Sponsor:
Virginia Commonwealth University
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00747838
First received: September 4, 2008
Last updated: October 10, 2011
Last verified: October 2011
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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 ]
| 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:
-
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:
- 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):
| 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 May 16, 2013