NCT01730924

Comparison of Pulmonary Vein Isolation Using SmartTouch® Catheter With or Without Real-time Contact Force Data

A Randomised Study Comparing Pulmonary Vein Isolation Using SmartTouch® Catheter With or Without Real-time Contact Force Data. The SMART Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Queen Mary University of London · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The most widely used approach for the invasive treatment of paroxysmal atrial fibrillation is catheter ablation, by which radiofrequency energy is used to heat the tip of an ablation catheter to deliver targeted burns on the inner surface of the heart. The aim of this approach is to cause electrical isolation of the pulmonary veins. The purpose of this study is to evaluate whether the information which can be derived from the latest catheter technologies - on the degree of contact force between the catheter and the heart - affects the time to perform the procedure, or the outcomes as a result of it. Patients undergoing pulmonary vein isolation will be randomised to having their procedure performed with the contact force information available to the operator, or not available. The time taken to achieve pulmonary vein isolation is the primary end-point of the study.

Conditions

• Atrial Fibrillation
• Atrial Fibrillation Ablation
• Pulmonary Vein Isolation

Interventions

Type	Name	Description
PROCEDURE	Pulmonary vein isolation using contact force sensing catheter

Timeline

• Start date: 2012-12-01
• Primary completion: 2014-12-01
• First posted: 2012-11-21
• Last updated: 2016-09-29

Locations

1 site across 1 country: United Kingdom