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Based on interim analysis study felt unlikely to reach the primary aim
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| manual ablation | Other |
| |
| robotic ablation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| catheter ablation | Procedure | ablation procedure performed with Hansen robotic navigation system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Single procedure success rate at 12 months | 12 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barts and the London NHS Trust | London | London | EC1A 7BE | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24960268 | Result | 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. | |
| 22494451 | Derived | 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. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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| catheter ablation | Procedure | Ablation will be performed as normal treatment |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |