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

Study Overview
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Brief Summary
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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.

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

Conditions
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Atrial Fibrillation, Atrial Fibrillation Ablation, Pulmonary Vein Isolation

Intervention / Treatment
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* Procedure: Pulmonary vein isolation using contact force sensing catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Contact force available<br> | Procedure: Pulmonary vein isolation using contact force sensing catheter<br> <br> |
| Other: Contact force not available<br> | Procedure: Pulmonary vein isolation using contact force sensing catheter<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to achieve pulmonary vein isolation in patients undergoing catheter ablation for paroxysmal atrial fibrillaiton |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Contact force, Ablation