This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been terminated.
(Based on interim analysis study felt unlikely to reach the primary aim)
Information provided by (Responsible Party):
Barts & The London NHS Trust Identifier:
First received: December 21, 2009
Last updated: July 9, 2014
Last verified: March 2014

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 Intervention Phase
Atrial Fibrillation Procedure: catheter ablation Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Barts & The London NHS Trust:

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

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

Enrollment: 166
Study Start Date: April 2008
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01037296

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Barts & The London NHS Trust Identifier: NCT01037296     History of Changes
Other Study ID Numbers: 005815
Study First Received: December 21, 2009
Last Updated: July 9, 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 processed this record on September 21, 2017