Catheter Ablation of Atrial Fibrillation Using Hansen Medical Robotic Navigation

Study Overview
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Brief Summary
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Atrial fibrillation (AF) affects as many as 1 in 100 people and reduces the quality of life of large numbers of people in the UK and around the world. Catheter ablation is a minimally invasive treatment that has been developed to help eliminate AF. It is a complex procedure to perform so only a few hospitals are able to offer this treatment in the UK. A new technology allows the operator to guide their catheters (thin wires) in the patient by using a robotically steered sheath. This allows accurate and precise navigation that may improve the accuracy and integrity of ablation. We aim to prove whether this technology can make AF ablation easier and more effective. Substudy: Platelet reactivity and activation in AF, and the impact of curative ablation. Blood and urine samples will be taken pre- and 3 months post ablation to see if platelet reactivity and activation are affected by AF compared to established normal ranges, and whether curative ablation impacts on this.

Official Title
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Catheter Ablation of Atrial Fibrillation Using Hansen Medical Robotic Navigation - A Randomised Controlled Trial

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: catheter ablation
* Procedure: catheter ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with symptomatic AF planned for catheter ablation. Exclusion Criteria: Age < 18 years Previous ablation procedure Expected life expectancy < 6 months Inability or unwillingness to sign consent Pregnancy Contraindications for the ablation procedure o Thrombus in the left atrium that fails to resolve with optimal oral anticoagulation therapy

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: manual ablation<br> | Procedure: catheter ablation<br>* Ablation will be performed as normal treatment<br>|
| Experimental: robotic ablation<br> | Procedure: catheter ablation<br>* ablation procedure performed with Hansen robotic navigation system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single procedure success rate at 12 months |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rates, catheter stability, procedure/fluoroscopy time (and dose), subjectively assessed operator fatigue |  | 0-12 months | 
| Platelet substudy: Platelet activation post ablation compared to baseline. |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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catheter ablation, robotic navigation