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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01730924
First Posted: November 21, 2012
Last Update Posted: September 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prof Richard Schilling, Queen Mary University of London
  Purpose
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.

Condition Intervention
Atrial Fibrillation Atrial Fibrillation Ablation Pulmonary Vein Isolation Procedure: Pulmonary vein isolation using contact force sensing catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomised Study Comparing Pulmonary Vein Isolation Using SmartTouch® Catheter With or Without Real-time Contact Force Data. The SMART Trial

Resource links provided by NLM:


Further study details as provided by Prof Richard Schilling, Queen Mary University of London:

Primary Outcome Measures:
  • Time to achieve pulmonary vein isolation in patients undergoing catheter ablation for paroxysmal atrial fibrillaiton

Estimated Enrollment: 120
Study Start Date: December 2012
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Contact force available Procedure: Pulmonary vein isolation using contact force sensing catheter
Contact force not available Procedure: Pulmonary vein isolation using contact force sensing catheter

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
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): NCT01730924


Locations
United Kingdom
Barts Health NHS Trust
London, United Kingdom, EC1A 7BE
Sponsors and Collaborators
Queen Mary University of London
  More Information

Responsible Party: Prof Richard Schilling, Professor of Cardiology, Queen Mary University of London
ClinicalTrials.gov Identifier: NCT01730924     History of Changes
Other Study ID Numbers: 008205 QM
First Submitted: November 15, 2012
First Posted: November 21, 2012
Last Update Posted: September 29, 2016
Last Verified: September 2016

Keywords provided by Prof Richard Schilling, Queen Mary University of London:
Atrial fibrillation
Contact force
Ablation

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