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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Virginia Commonwealth University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00571597
First received: December 10, 2007
Last updated: June 3, 2008
Last verified: June 2008
History of Changes
  Purpose

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


Condition
Atrial Fibrillation

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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

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

No publications provided

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

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

ClinicalTrials.gov processed this record on May 23, 2013