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Catheter Ablation of Atrial Fibrillation Using Hansen Medical Robotic Navigation

This study has been terminated.
(Based on interim analysis study felt unlikely to reach the primary aim)
Sponsor:
Information provided by (Responsible Party):
Barts & The London NHS Trust
ClinicalTrials.gov Identifier:
NCT01037296
First received: December 21, 2009
Last updated: July 9, 2014
Last verified: March 2014
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complication rates, catheter stability, procedure/fluoroscopy time (and dose), subjectively assessed operator fatigue [ Time Frame: 0-12 months ] [ Designated as safety issue: No ]
  • Platelet substudy: Platelet activation post ablation compared to baseline. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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 ClinicalTrials.gov identifier: NCT01037296

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

Publications:
Additional 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
Study First Received: December 21, 2009
Last Updated: July 9, 2014
Health Authority: London: Redbridge and Waltham Local Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 19, 2014