A Study of Strategies for Electrical Isolation of Pulmonic Veins for Curative Treatment of Atrial Fibrillation

Completed · Not applicable

Conditions studied: Atrial Fibrillation

In brief

This is a study of different techniques for treatment of atrial fibrillation using a procedure called radiofrequency catheter ablation. Atrial fibrillation (called AF) is when the upper chambers of the heart (the atria) beat much faster than the lower chambers, causing the heart to beat less effectively. AF can cause stroke, impaired performance, palpitations, shortness of breath, passing out and other symptoms. Radiofrequency ablation involves placement of catheter/electrode wires into the heart through plastic tubes inserted into veins / arteries in both the groins and the right side of the neck under local anesthesia. Radiofrequency energy is delivered to the areas inside the heart that cause the rapid firing of the atria, causing small lesions or "burns" that destroy the heart tissue where the extra electrical impulses come from. Commonly this area is where the four pulmonary veins (PV) deliver blood from the lungs to the left side of the heart, and the procedure is also referred to as "pulmonary vein isolation" or PVI. This study compares two different strategies for performing the pulmonary vein isolation procedure, and compares the effect using two different types of radiofrequency ablation catheters.

Key facts

Study ID

NCT00434694

Run by

University of Pennsylvania

People needed

300

Starts

2003-07-01

Expected to finish

2006-02-01

Last updated by the study team

2015-11-25

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All pts of age 40 years or over that are referred to our center for ablation of AF and meet the clinical criteria to undergo the procedure shall be eligible to participate in the study.

You may not qualify if…

• Failure to obtain informed consent
• Age < 40 years
• Despite the reported low incidence of pulmonic vein stenosis (0.8%) as a potential complication of PV isolation in pts undergoing AF ablation, in younger pts where it appears that AF results mostly from foci from a limited number of PVs, we feel that including them in the current study with a possibility of having all 4 PVs isolated cannot be justified.

Where it is running

• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Presbyterian Medical Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.