Comparison of Pulmonary Vein Isolation Using SmartTouch® Catheter With or Without Real-time Contact Force Data

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Queen Mary University of London
Sponsor:
Information provided by (Responsible Party):
Prof Richard Schilling, Queen Mary University of London
ClinicalTrials.gov Identifier:
NCT01730924
First received: November 15, 2012
Last updated: January 17, 2013
Last verified: January 2013

November 15, 2012
January 17, 2013
December 2012
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Time to achieve pulmonary vein isolation in patients undergoing catheter ablation for paroxysmal atrial fibrillaiton [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01730924 on ClinicalTrials.gov Archive Site
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Comparison of Pulmonary Vein Isolation Using SmartTouch® Catheter With or Without Real-time Contact Force Data
A Randomised Study Comparing Pulmonary Vein Isolation Using SmartTouch® Catheter With or Without Real-time Contact Force Data. The SMART Trial

The most widely used approach for the invasive treatment of paroxysmal atrial fibrillation is catheter ablation, by which radiofrequency energy is used to heat the tip of an ablation catheter to deliver targeted burns on the inner surface of the heart. The aim of this approach is to cause electrical isolation of the pulmonary veins. The purpose of this study is to evaluate whether the information which can be derived from the latest catheter technologies - on the degree of contact force between the catheter and the heart - affects the time to perform the procedure, or the outcomes as a result of it. Patients undergoing pulmonary vein isolation will be randomised to having their procedure performed with the contact force information available to the operator, or not available. The time taken to achieve pulmonary vein isolation is the primary end-point of the study.

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Interventional
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Allocation: Randomized
  • Atrial Fibrillation
  • Atrial Fibrillation Ablation
  • Pulmonary Vein Isolation
Procedure: Pulmonary vein isolation using contact force sensing catheter
  • Contact force available
    Intervention: Procedure: Pulmonary vein isolation using contact force sensing catheter
  • Contact force not available
    Intervention: Procedure: Pulmonary vein isolation using contact force sensing catheter
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
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Inclusion Criteria:

Age > 18 years, Symptomatic paroxysmal atrial fibrillation (defined as ECG proven episodes of atrial fibrillation which are self limiting and last less than 7 days on each occasion)

Exclusion Criteria:

Inability or unwillingness to receive oral anticoagulation Previous ablation procedure for atrial fibrillation Unwillingness or inability to complete the required follow up arrangements Persistent atrial fibrillation Prior prosthetic mitral valve replacement or severe structural cardiac abnormality Known severe left ventricular systolic function (ejection fraction <35%) Known hypertrophic or infiltrative cardiomyopathy

Both
18 Years to 85 Years
No
Contact: Richard Schilling 02034656763 bartscardiacresearch@bartshealth.nhs.uk
United Kingdom
 
NCT01730924
008205 QM
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Prof Richard Schilling, Queen Mary University of London
Queen Mary University of London
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Queen Mary University of London
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP