Prophylactic Pulmonary Vein Isolation Study
Primary Purpose
Atrial Fibrillation
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pulmonary Vein Isolation
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, AF, A fib, cardiac ablation, modified maze procedure
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
1
2
Arm Description
The treatment group will undergo operation for mitral valve disease with an additional procedure called Pulmonary Vein Isolation.
The control group of patients will undergo operation for mitral valve disease without the additional Pulmonary Vein Isolation
Outcomes
Primary Outcome Measures
Evaluated by the number of patients free of taking antiarrhythmic medications and free of AF as determined by a 24-hour Holter recording.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00587899
Brief Title
Prophylactic Pulmonary Vein Isolation Study
Official Title
A Randomized, Single-blind Prophylactic Pulmonary Vein Isolation Procedure Utilizing Bipolar Radiofrequency Ablation in Patients Undergoing Mitral Valve Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Terminated
Why Stopped
enrollment has been lower than anticipated due to growth in the minimally invasive mitral valve repair practice.
Study Start Date
January 2007 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation, AF, A fib, cardiac ablation, modified maze procedure
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
The treatment group will undergo operation for mitral valve disease with an additional procedure called Pulmonary Vein Isolation.
Arm Title
2
Arm Type
No Intervention
Arm Description
The control group of patients will undergo operation for mitral valve disease without the additional Pulmonary Vein Isolation
Intervention Type
Procedure
Intervention Name(s)
Pulmonary Vein Isolation
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thoralf M. Sundt, III, M.D.
Organizational Affiliation
Professor of Surgery, Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
12. IPD Sharing Statement
Links:
URL
http://clinicaltrials.mayo.edu
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Prophylactic Pulmonary Vein Isolation Study
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