Atrial Fibrillation Force Contact Ablation Study (CAFCAS)
|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.|
|ClinicalTrials.gov Identifier: NCT01693107|
Recruitment Status : Unknown
Verified September 2012 by Peter Leong-Sit, Lawson Health Research Institute.
Recruitment status was: Not yet recruiting
First Posted : September 26, 2012
Last Update Posted : September 26, 2012
This study will be divided into two phases. The purpose of the Phase I registry is to assess the current force being used for ablation of symptomatic paroxysmal AF in a wide range of operators in different Canadian centres with the operators being blinded to the contact force data.
In Phase II of the study, operators will have open use of the force contact data. Phase I and II data will be compared in order to assess the efficiency of using the THERMOCOOL® SMARTTOUCH™ catheter.
|Condition or disease|
|Paroxysmal Atrial Fibrillation|
Atrial fibrillation (AF) is the most common arrhythmia affecting over 5% of the population above the age of 65 years. The use of percutaneous catheter ablation for symptomatic management has increased over the last decade. It is well established that AF ablation is superior to anti-arrhythmic drugs for symptomatic recurrence of AF. Despite this, success rates with a single procedure for paroxysmal AF is approximately 80% with the majority of recurrence due to recovery of lesions or "gaps" found at repeat procedures.
In this study, patients with symptomatic paroxysmal atrial fibrillation (AF) will undergo ablation using a newly Health Canada approved catheter with SmartTouch technology that enables the measurement of catheter tip contact force and direction inside the heart. The purpose of Phase I of the study is to assess the current force being used for ablation of symptomatic paroxysmal AF in a wide range of operators in different Canadian centres with the operators being blinded to the contact force data.
The secondary objective will be to assess whether lesion recovery, as assessed in redo procedures, corresponds to contact force measurements. It is hypothesized that gaps found on repeat procedures will correspond to ablation lesions associated with a lower contact force.
In Phase II, operators will have open use of the force contact data. Phase I and II data will be compared in order to assess the efficiency of using the SmartTouch catheter. It is hypothesized that the open use of contact force data will decrease the procedural time and number of lesions to achieve bidirectional pulmonary vein isolation.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||The Canadian Atrial Fibrillation Force Contact Ablation Study|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||January 2015|
Operator Blinded to Contact Force
Physicians performing the ablation will be blinded to the contact force data
- Procedural Time [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 36 hours ]Length of time between first ablation and last ablation
- Lesion Recovery [ Time Frame: up to 1 year ]Localization of recovered gaps
- Ablation Time [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 36 hours ]Total time of ablation used during procedure
- Number of ablation lesions [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 36 hours ]Total number of ablation lesions to achieve bidirectional block of all 4 pulmonary veins
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): NCT01693107
|Contact: Cathy Bentley, RN||519-685-8500 ext firstname.lastname@example.org|
|Contact: Lynn Nyman, RN||519-685-8500 ext email@example.com|
|London Health Sciences Centre||Not yet recruiting|
|London, Ontario, Canada, N6A 5A5|
|Principal Investigator:||Peter Leong-Sit, MD||Western University|