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NCT00747838 Clinical Trial

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

Atrial Fibrillation Clinical Trial

— STAR  

Official title:
Surgical Treatment for Atrial Arrhythmia Registry (STAR Outcomes)

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00747838
Other study ID # STAR Outcomes
Secondary ID
Status Terminated
Phase N/A
First received September 4, 2008
Last updated May 24, 2013
Start date September 2008
Est. completion date December 2012

Study information
Verified date May 2013
Source Virginia Commonwealth University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 106
Est. completion date December 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Minimally Invasive Maze Procedure
Minimally Invasive Surgical Correction of Atrial Fibrillation.

Locations
Country Name City State
United States Virginia Commonwealth University Richmond Virginia

Sponsors (1)
Lead Sponsor Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Minimally invasive surgical treatment of atrial fibrillation is safe and effective at controlling atrial fibrillation One Year No
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