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

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ClinicalTrials.gov Identifier: NCT00571597
Recruitment Status : Completed
First Posted : December 12, 2007
Last Update Posted : April 14, 2014
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

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

Condition or disease
Atrial Fibrillation

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.

Study Type : Observational
Actual Enrollment : 118 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Analysis of the Wolf Minimaze Procedure for Treatment of Atrial Fibrillation
Study Start Date : March 2007
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Transtelephonic monitoring for the identification of post surgical Atrial Fibrillation [ Time Frame: six months and 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00571597


Locations
United States, Virginia
Division of Cardiology Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Kenneth A Ellenbogen, MD Virginia Commonwealth University

Publications of Results:
Other Publications:
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00571597     History of Changes
Other Study ID Numbers: HM10695
First Posted: December 12, 2007    Key Record Dates
Last Update Posted: April 14, 2014
Last Verified: April 2014

Keywords provided by Virginia Commonwealth University:
surgery
ablation
radiofrequency
minimaze
transtelephonic monitoring

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes