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Catheter Ablation of Atrial Fibrillation Using Hansen Medical Robotic Navigation (Hansen)

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ClinicalTrials.gov Identifier: NCT01037296
Recruitment Status : Terminated (Based on interim analysis study felt unlikely to reach the primary aim)
First Posted : December 23, 2009
Last Update Posted : July 10, 2014
Sponsor:
Information provided by (Responsible Party):
Barts & The London NHS Trust

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: catheter ablation Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Catheter Ablation of Atrial Fibrillation Using Hansen Medical Robotic Navigation - A Randomised Controlled Trial
Study Start Date : April 2008
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
manual ablation Procedure: catheter ablation
Ablation will be performed as normal treatment
Experimental: robotic ablation Procedure: catheter ablation
ablation procedure performed with Hansen robotic navigation system



Primary Outcome Measures :
  1. Single procedure success rate at 12 months [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Complication rates, catheter stability, procedure/fluoroscopy time (and dose), subjectively assessed operator fatigue [ Time Frame: 0-12 months ]
  2. Platelet substudy: Platelet activation post ablation compared to baseline. [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01037296


Locations
United Kingdom
Barts and the London NHS Trust
London, United Kingdom, EC1A 7BE
Sponsors and Collaborators
Barts & The London NHS Trust

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT01037296     History of Changes
Other Study ID Numbers: 005815
First Posted: December 23, 2009    Key Record Dates
Last Update Posted: July 10, 2014
Last Verified: March 2014

Keywords provided by Barts & The London NHS Trust:
catheter ablation
robotic navigation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes