NCT01037296

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P25-P50 for phase_4 atrial-fibrillation

Timeline
Completed

Started Apr 2008

Longer than P75 for phase_4 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2009

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

July 10, 2014

Status Verified

March 1, 2014

Enrollment Period

5.4 years

First QC Date

December 21, 2009

Last Update Submit

July 9, 2014

Conditions

Atrial Fibrillation

Keywords

catheter ablationrobotic navigation

Outcome Measures

Primary Outcomes (1)

  • Single procedure success rate at 12 months

    12 months

Secondary Outcomes (2)

  • 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

Study Arms (2)

manual ablation

OTHER
Procedure: catheter ablation

robotic ablation

EXPERIMENTAL
Procedure: catheter ablation

Interventions

catheter ablationPROCEDURE

ablation procedure performed with Hansen robotic navigation system

robotic ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with symptomatic AF planned for catheter ablation.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barts and the London NHS Trust

London, London, EC1A 7BE, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 24960268RESULT

  • 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.

    PMID: 22494451DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2009

First Posted

December 23, 2009

Study Start

April 1, 2008

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

July 10, 2014

Record last verified: 2014-03

Locations

GB(1)