Short Term Outcomes From Minimally Invasive Surgery for the Treatment of Atrial Fibrillation

This study is currently recruiting participants.

Verified by Virginia Commonwealth University, June 2008

Sponsored by:	Virginia Commonwealth University
Information provided by:	Virginia Commonwealth University
ClinicalTrials.gov Identifier:	NCT00571597

Purpose

The purpose of this study is to assess the efficacy of minimally invasive surgery for atrial fibrillation.

Condition
Atrial Fibrillation

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Prospective Analysis of the Wolf Minimaze Procedure for Treatment of Atrial Fibrillation

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:

Transtelephonic monitoring for the identification of post surgical Atrial Fibrillation [ Time Frame: six months and 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	47
Study Start Date:	March 2007
Estimated Study Completion Date:	December 2008

Detailed Description:

Patients who are undergoing or who have undergone minimally invasive surgery for atrial fibrillation will be followed prospectively. At 6 to 9 months, 1 and two years post surgery follow-up subjects will receive a trans-telephonic monitor to wear for approximately 1 month, and will submit transmissions on a daily basis. Episodes of atrial fibrillation will be documented during this time. The overall efficacy of the procedure will be assessed based on the freedom from atrial fibrillation at the time of transtelephonic monitoring.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Eligible subjects will be male or females age 18-85 that have elected to undergo or have undergone a minimally invasive "minimaze" surgery for the treatment of atrial firillation

Criteria

Inclusion Criteria:

18 or older
paroxysmal, persistent, or permanent atrial fibrillation

Exclusion Criteria:

concomitant heart surgery requiring open thoracotomy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571597

Contacts

Contact: Kenneth A Ellenbogen, MD	804-828-7576	kellenbogen@mcvh-vcu.edu
Contact: Geoffrey A Newton, RN	804-628-2520	gnewton@mcvh-vcu.edu

Locations

United States, Virginia
Division of Cardiology Virginia Commonwealth University	Recruiting
Richmond, Virginia, United States, 23298
Contact: Kenneth A Ellenbogen, MD 804-828-7565 kellenbogen@pol.net
Contact: Kim Hall, R.N. 804-828-7565

Sponsors and Collaborators

Virginia Commonwealth University

Investigators

Principal Investigator:

Kenneth A Ellenbogen, MD

Virginia Commonwealth University

More Information

Responsible Party:	Virginia Commonwealth University ( Dr Kenneth Ellenbogen, MD )
Study ID Numbers:	HM10695
Study First Received:	December 10, 2007
Last Updated:	June 3, 2008
ClinicalTrials.gov Identifier:	NCT00571597
Health Authority:	United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:

surgery
ablation
radiofrequency
minimaze
transtelephonic monitoring

Study placed in the following topic categories:

Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 13, 2009