Prophylactic Pulmonary Vein Isolation Study

Sponsor

Mayo Clinic (Other)

Overall Status

Terminated

CT.gov ID

NCT00587899

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Procedure: Pulmonary Vein Isolation	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

A Randomized, Single-blind Prophylactic Pulmonary Vein Isolation Procedure Utilizing Bipolar Radiofrequency Ablation in Patients Undergoing Mitral Valve Surgery

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Nov 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: 1 The treatment group will undergo operation for mitral valve disease with an additional procedure called Pulmonary Vein Isolation.	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.
No Intervention: 2 The control group of patients will undergo operation for mitral valve disease without the additional Pulmonary Vein Isolation

Arm

Intervention/Treatment

Other: 1

The treatment group will undergo operation for mitral valve disease with an additional procedure called Pulmonary Vein Isolation.

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

Outcome Measures

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. [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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