Prophylactic Pulmonary Vein Isolation Study

Atrial Fibrillation Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation

• NCT number: NCT00587899
• Study type: Interventional
• Source: Mayo Clinic
• Status: Terminated
• Phase: N/A
• Start date: January 2007
• Completion date: November 2009