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Prophylactic Pulmonary Vein Isolation Study

This study has been terminated.
(enrollment has been lower than anticipated due to growth in the minimally invasive mitral valve repair practice.)
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587899
First received: December 22, 2007
Last updated: April 12, 2011
Last verified: April 2011

December 22, 2007
April 12, 2011
January 2007
November 2009   (final data collection date for primary outcome measure)
Evaluated by the number of patients free of taking antiarrhythmic medications and free of AF as determined by a 24-hour Holter recording. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00587899 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Prophylactic Pulmonary Vein Isolation Study
A Randomized, Single-blind Prophylactic Pulmonary Vein Isolation Procedure Utilizing Bipolar Radiofrequency Ablation in Patients Undergoing Mitral Valve Surgery

This study is being done to learn the effects of the Pulmonary Vein Isolation in patients that are at high risk to developing, but do not have a documented history of atrial fibrillation.

Patients with a dilated left atrium (left upper chamber of the heart) that undergo mitral valve surgery may be at risk for the development of atrial fibrillation after surgery.

Atrial fibrillation (also known as "A-Fib" or AF) is an abnormal heart rhythm which may cause symptoms such as pounding sensations in your chest, dizziness, fatigue, chest pain and/or shortness of breath. AF patients are at a higher risk of developing a stroke.

Participants who sign informed consent will be randomized into one of two groups by chance (as in the flip of a coin).

Approximately 77 patients will undergo their mitral valve operation along with Pulmonary Vein Isolation (a treatment group) and 77 patients who do not undergo Pulmonary Vein Isolation at the time of their mitral valve surgery (a control group).

The treatment group will undergo operation for mitral valve disease with an additional procedure called Pulmonary Vein Isolation using a device that delivers radiofrequency energy to the heart muscle in order to create scar tissue to block electrical impulses that can trigger episodes of AF.

The control group of patients will undergo operation for mitral valve disease without the additional Pulmonary Vein Isolation.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Atrial Fibrillation
Procedure: Pulmonary Vein Isolation
The treatment group will undergo operation for mitral valve disease with an additional procedure called Pulmonary Vein Isolation using a device that delivers radiofrequency energy to the heart muscle in order to create scar tissue to block electrical impulses that can trigger episodes of AF.
  • 1
    The treatment group will undergo operation for mitral valve disease with an additional procedure called Pulmonary Vein Isolation.
    Intervention: Procedure: Pulmonary Vein Isolation
  • No Intervention: 2
    The control group of patients will undergo operation for mitral valve disease without the additional Pulmonary Vein Isolation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
41
November 2009
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Indication for open-heart surgery: Mitral valve repair or replacement, evidence of a dilated left atrium

Exclusion Criteria:

  • History of Atrial Fibrillation
  • Need for emergent cardiac surgery
  • Previous cardiac surgery
  • Preoperative need for an intraaortic balloon pump or intravenous inotropes
  • Current diagnosis of active endocarditis
  • Mental impairment/or experience other conditions which may not allow subject to understand nature
  • Significance and scope of study
  • Pregnancy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00587899
06-005543
No
Thoralf, M. Sundt, III, Principal Investigator, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Thoralf M. Sundt, III, M.D. Professor of Surgery, Mayo Clinic
Mayo Clinic
April 2011

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