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

NCT ID: NCT00747838

Last Updated: 2013-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Minimally Invasive Maze Procedure

Minimally Invasive Surgical Correction of Atrial Fibrillation.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vigneshwar Kasirajan, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Kenneth Ellenbogen, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 28438723 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22541178 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20156608 (View on PubMed)

Other Identifiers

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STAR Outcomes

Identifier Type: -

Identifier Source: org_study_id

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