Comparison of Pulmonary Vein Isolation Using SmartTouch® Catheter With or Without Real-time Contact Force Data
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Atrial Fibrillation Atrial Fibrillation Ablation Pulmonary Vein Isolation |
Procedure: Pulmonary vein isolation using contact force sensing catheter |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized |
| Official Title: | A Randomised Study Comparing Pulmonary Vein Isolation Using SmartTouch® Catheter With or Without Real-time Contact Force Data. The SMART Trial |
- Time to achieve pulmonary vein isolation in patients undergoing catheter ablation for paroxysmal atrial fibrillaiton [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | December 2012 |
| Arms | Assigned Interventions |
|---|---|
| Contact force available | Procedure: Pulmonary vein isolation using contact force sensing catheter |
| Contact force not available | Procedure: Pulmonary vein isolation using contact force sensing catheter |
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Age > 18 years, Symptomatic paroxysmal atrial fibrillation (defined as ECG proven episodes of atrial fibrillation which are self limiting and last less than 7 days on each occasion)
Exclusion Criteria:
Inability or unwillingness to receive oral anticoagulation Previous ablation procedure for atrial fibrillation Unwillingness or inability to complete the required follow up arrangements Persistent atrial fibrillation Prior prosthetic mitral valve replacement or severe structural cardiac abnormality Known severe left ventricular systolic function (ejection fraction <35%) Known hypertrophic or infiltrative cardiomyopathy
Contacts and Locations| Contact: Richard Schilling | 02034656763 | bartscardiacresearch@bartshealth.nhs.uk |
| United Kingdom | |
| Barts Health NHS Trust | Recruiting |
| London, United Kingdom, EC1A 7BE | |
| Contact: Richard Schilling 02034656763 bartscardiacresearch@bartshealth.nhs.uk | |
| Principal Investigator: Richard Schilling | |
More Information
No publications provided
| Responsible Party: | Prof Richard Schilling, Professor of Cardiology, Queen Mary University of London |
| ClinicalTrials.gov Identifier: | NCT01730924 History of Changes |
| Other Study ID Numbers: | 008205 QM |
| Study First Received: | November 15, 2012 |
| Last Updated: | January 17, 2013 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by Queen Mary University of London:
|
Atrial fibrillation Contact force Ablation |
Additional relevant MeSH terms:
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013