Catheter Ablation of Atrial Fibrillation Using Hansen Medical Robotic Navigation

NCT ID: NCT01037296

Last Updated: 2014-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2013-09-30

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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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manual ablation

Group Type OTHER

catheter ablation

Intervention Type PROCEDURE

Ablation will be performed as normal treatment

robotic ablation

Group Type EXPERIMENTAL

catheter ablation

Intervention Type PROCEDURE

ablation procedure performed with Hansen robotic navigation system

Interventions

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catheter ablation

ablation procedure performed with Hansen robotic navigation system

Intervention Type PROCEDURE

catheter ablation

Ablation will be performed as normal treatment

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Barts & The London NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Barts and the London NHS Trust

London, London, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type RESULT
PMID: 24960268 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22494451 (View on PubMed)

Other Identifiers

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005815

Identifier Type: -

Identifier Source: org_study_id

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