Back to resultsCatheter Ablation of Atrial Fibrillation Using Hansen Medical Robotic Navigation (Hansen)
Primary Purpose
Atrial Fibrillation
Status
Terminated
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
catheter ablation
catheter ablation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring catheter ablation, robotic navigation
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
Sites / Locations
- Barts and the London NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
manual ablation
robotic ablation
Arm Description
Outcomes
Primary Outcome Measures
Single procedure success rate at 12 months
Secondary Outcome Measures
Complication rates, catheter stability, procedure/fluoroscopy time (and dose), subjectively assessed operator fatigue
Platelet substudy: Platelet activation post ablation compared to baseline.
Full Information
NCT ID
NCT01037296
First Posted
December 21, 2009
Last Updated
July 9, 2014
Sponsor
Barts & The London NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT01037296
Brief Title
Catheter Ablation of Atrial Fibrillation Using Hansen Medical Robotic Navigation
Acronym
Hansen
Official Title
Catheter Ablation of Atrial Fibrillation Using Hansen Medical Robotic Navigation - A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Terminated
Why Stopped
Based on interim analysis study felt unlikely to reach the primary aim
Study Start Date
April 2008 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barts & The London NHS Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
catheter ablation, robotic navigation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
166 (Actual)
8. Arms, Groups, and Interventions
Arm Title
manual ablation
Arm Type
Other
Arm Title
robotic ablation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
catheter ablation
Intervention Description
ablation procedure performed with Hansen robotic navigation system
Intervention Type
Procedure
Intervention Name(s)
catheter ablation
Intervention Description
Ablation will be performed as normal treatment
Primary Outcome Measure Information:
Title
Single procedure success rate at 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Complication rates, catheter stability, procedure/fluoroscopy time (and dose), subjectively assessed operator fatigue
Time Frame
0-12 months
Title
Platelet substudy: Platelet activation post ablation compared to baseline.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Barts and the London NHS Trust
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
24960268
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.
Results Reference
result
PubMed Identifier
22494451
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.
Results Reference
derived
Learn more about this trial
Catheter Ablation of Atrial Fibrillation Using Hansen Medical Robotic Navigation
We'll reach out to this number within 24 hrs