Clinical trial NCT01037296: Catheter Ablation of Atrial Fibrillation Using Hansen Medical Robotic Navigation
Official title: Catheter Ablation of Atrial Fibrillation Using Hansen Medical Robotic Navigation - A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: catheter ablation
robotic navigation
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
First posted: 2009-12-23
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Single procedure success rate at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Complication rates, catheter stability, procedure/fluoroscopy time (and dose), subjectively assessed operator fatigue
timeFrame: 0-12 months
measure: Platelet substudy: Platelet activation post ablation compared to baseline.
timeFrame: 3 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Barts and the London NHS Trust
Study officials:
References:
citation: Ullah W, McLean A, Hunter RJ, Baker V, Richmond L, Cantor EJ, Dhinoja MB, Sporton S, Earley MJ, Schilling RJ. Randomized trial comparing robotic to manual ablation for atrial fibrillation. Heart Rhythm. 2014 Nov;11(11):1862-9. doi: 10.1016/j.hrthm.2014.06.026. Epub 2014 Jun 21.
citation: Duncan ER, Finlay M, Page SP, Hunter R, Goromonzi F, Richmond L, Baker V, Ginks M, Ezzat V, Dhinoja M, Earley MJ, Sporton S, Schilling RJ. Improved electrogram attenuation during ablation of paroxysmal atrial fibrillation with the Hansen robotic system. Pacing Clin Electrophysiol. 2012 Jun;35(6):730-8. doi: 10.1111/j.1540-8159.2012.03381.x. Epub 2012 Apr 11.