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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00571597
First Posted: December 12, 2007
Last Update Posted: April 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Virginia Commonwealth University
December 10, 2007
December 12, 2007
April 14, 2014
March 2007
May 2012   (Final data collection date for primary outcome measure)
Transtelephonic monitoring for the identification of post surgical Atrial Fibrillation [ Time Frame: six months and 1 year ]
Same as current
Complete list of historical versions of study NCT00571597 on ClinicalTrials.gov Archive Site
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Short Term Outcomes From Minimally Invasive Surgery for the Treatment of Atrial Fibrillation
Prospective Analysis of the Wolf Minimaze Procedure for Treatment of Atrial Fibrillation
The purpose of this study is to assess the efficacy of minimally invasive surgery for atrial fibrillation.
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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
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
Atrial Fibrillation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
118
May 2012
May 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 or older
  • paroxysmal, persistent, or permanent atrial fibrillation

Exclusion Criteria:

  • concomitant heart surgery requiring open thoracotomy
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00571597
HM10695
No
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Virginia Commonwealth University
Virginia Commonwealth University
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Principal Investigator: Kenneth A Ellenbogen, MD Virginia Commonwealth University
Virginia Commonwealth University
April 2014