Back to resultsComparison of Pulmonary Vein Isolation Using SmartTouch® Catheter With or Without Real-time Contact Force Data
Primary Purpose
Atrial Fibrillation, Atrial Fibrillation Ablation, Pulmonary Vein Isolation
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Pulmonary vein isolation using contact force sensing catheter
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Contact force, Ablation
Eligibility 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
Sites / Locations
- Barts Health NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Contact force available
Contact force not available
Arm Description
Outcomes
Primary Outcome Measures
Time to achieve pulmonary vein isolation in patients undergoing catheter ablation for paroxysmal atrial fibrillaiton
Secondary Outcome Measures
Full Information
NCT ID
NCT01730924
First Posted
November 15, 2012
Last Updated
September 28, 2016
Sponsor
Queen Mary University of London
1. Study Identification
Unique Protocol Identification Number
NCT01730924
Brief Title
Comparison of Pulmonary Vein Isolation Using SmartTouch® Catheter With or Without Real-time Contact Force Data
Official Title
A Randomised Study Comparing Pulmonary Vein Isolation Using SmartTouch® Catheter With or Without Real-time Contact Force Data. The SMART Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen Mary University of London
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Atrial Fibrillation Ablation, Pulmonary Vein Isolation
Keywords
Atrial fibrillation, Contact force, Ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Contact force available
Arm Type
Other
Arm Title
Contact force not available
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Pulmonary vein isolation using contact force sensing catheter
Primary Outcome Measure Information:
Title
Time to achieve pulmonary vein isolation in patients undergoing catheter ablation for paroxysmal atrial fibrillaiton
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Barts Health NHS Trust
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
27173976
Citation
Ullah W, McLean A, Tayebjee MH, Gupta D, Ginks MR, Haywood GA, O'Neill M, Lambiase PD, Earley MJ, Schilling RJ; UK Multicentre Trials Group**. Randomized trial comparing pulmonary vein isolation using the SmartTouch catheter with or without real-time contact force data. Heart Rhythm. 2016 Sep;13(9):1761-7. doi: 10.1016/j.hrthm.2016.05.011. Epub 2016 May 9.
Results Reference
derived
Learn more about this trial
Comparison of Pulmonary Vein Isolation Using SmartTouch® Catheter With or Without Real-time Contact Force Data
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