Validation Durability Adenosine Effect in Verification Pulmonary Vein Isolation

Atrial Fibrillation Clinical Trial

Official title: Validation of the Durability of the Adenosine Effect in Verification of Pulmonary Vein Isolation

Status Completed

Clinical Trial Summary

Adenosine is used clinically to assess permanency of electrical isolation of pulmonary veins during atrial fibrillation ablation, however, the methodology has not been validated either in terms of the reproducibility of the adenosine response or the effect on clinical outcomes, namely whether using pulmonary vein reconnection to guide additional ablation lowers rate recurrent atrial fibrillation post ablation. Study will test the hypothesis that the response to adenosine used in this manner is reproducible over time.

Clinical Trial Description

Patients undergoing pulmonary vein isolation as part of atrial fibrillation ablation will be randomized to treatment and control groups. Treatment group subjects will received 12 mg IV adenosine to evaluate pulmonary vein reconnection after initial electrical isolation is documented. If electrical reconnection is not observed at 5 minutes, a second dose of adenosine will be administered, monitoring again for electrical reconnection. Control patients will be observed for 10 minutes post initial electrical isolation of the pulmonary vein for spontaneous electrical reconnection. If reconnection is observed, veins will be re-isolated per standard clinical practice. This procedure will be repeated for each of a patient's pulmonary veins. Patients will be followed up at clinical visits to examine for adverse effects of procedure and/or adenosine administration as well as atrial fibrillation recurrence. ;

Related Conditions & MeSH terms

• Atrial Fibrillation

• NCT number: NCT01590875
• Study type: Interventional
• Source: Medical College of Wisconsin
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Completion date: June 2015