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

NCT00747838 | Terminated

• 1 other identifier: STAR Outcomes
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Afib; Atrial Fibrillation; Maze; Mini-Maze

Outcome Measures

Primary Outcomes (1)

• Minimally invasive surgical treatment of atrial fibrillation is safe and effective at controlling atrial fibrillation

  One Year

Interventions

Minimally Invasive Maze Procedure PROCEDURE

Minimally Invasive Surgical Correction of Atrial Fibrillation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with paroxysmal (intermittent) or persistent atrial fibrillation undergoing surgical correction.

You may qualify if:

• Adult patients with paroxysmal (intermittent) or persistent atrial fibrillation
• \> 18 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (3)

• 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.

  PMID: 28438723 DERIVED

• 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.

  PMID: 22541178 DERIVED

• 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.

  PMID: 20156608 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vigneshwar Kasirajan, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

• Kenneth Ellenbogen, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2008
• First Posted: September 5, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 27, 2013

Record last verified: 2013-05

Locations

US (1)