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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00571597
First received: December 10, 2007
Last updated: April 10, 2014
Last verified: April 2014

December 10, 2007
April 10, 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 ] [ Designated as safety issue: No ]
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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00571597
HM10695
No
Virginia Commonwealth University
Virginia Commonwealth University
Not Provided
Principal Investigator: Kenneth A Ellenbogen, MD Virginia Commonwealth University
Virginia Commonwealth University
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP